{"id":"eptinezumab","rwe":[{"pmid":"41886713","year":"2026","title":"Eptinezumab With Patient Education for Chronic Migraine and Medication-Overuse Headache: The Randomized, Placebo-Controlled RESOLUTION Trial.","finding":"","journal":"Neurology","studyType":"Clinical Study"},{"pmid":"41851246","year":"2026","title":"Identification and validation of NETs-associated biomarkers in osteoporosis with diabetes.","finding":"","journal":"Scientific reports","studyType":"Clinical Study"},{"pmid":"41834318","year":"2026","title":"Long-Term Improvements Following Initial Migraine Response in Eptinezumab-Treated Participants With Migraine for Whom 2-4 Prior Preventive Treatments Have Failed.","finding":"","journal":"European journal of neurology","studyType":"Clinical Study"},{"pmid":"41834180","year":"2026","title":"Post-marketing safety of CGRP monoclonal antibodies and gepants: A systematic review of spontaneous reporting system data.","finding":"","journal":"Headache","studyType":"Clinical Study"},{"pmid":"41797154","year":"2026","title":"Sleep and anti-calcitonin gene related (CGRP) drugs: current evidence and perspectives.","finding":"","journal":"Sleep medicine reviews","studyType":"Clinical Study"}],"_fda":{"id":"9984df0e-33b9-4610-989d-0e186a7ee9e0","set_id":"79065861-6aa5-4d1f-829f-3a6471286b36","openfda":{"nui":["N0000193952","N0000193953"],"unii":["8202AY8I7H"],"route":["INTRAVENOUS"],"rxcui":["2283049","2283054"],"spl_id":["9984df0e-33b9-4610-989d-0e186a7ee9e0"],"brand_name":["Vyepti"],"spl_set_id":["79065861-6aa5-4d1f-829f-3a6471286b36"],"package_ndc":["67386-130-51","67386-130-91"],"product_ndc":["67386-130"],"generic_name":["EPTINEZUMAB-JJMR"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["EPTINEZUMAB"],"pharm_class_epc":["Calcitonin Gene-related Peptide Antagonist [EPC]"],"pharm_class_moa":["Calcitonin Gene-related Peptide Antagonists [MoA]"],"manufacturer_name":["Lundbeck Pharmaceuticals LLC"],"application_number":["BLA761119"],"is_original_packager":[true]},"version":"25","pregnancy":["8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VYEPTI during pregnancy. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-855-810-8549 or by contacting the company at www.vyeptipregnancyregistry.lundbeck.com. Risk Summary There are no adequate data on developmental risks associated with the use of VYEPTI in pregnant women. No adverse developmental effects were observed following administration of eptinezumab-jjmr to pregnant animals at doses greater than those used clinically [see Data] . In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. The estimated rate of major birth defects (2.2%-2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy. Data Animal Data When eptinezumab-jjmr (0, 75, or 150 mg/kg) was administered weekly to female rats and rabbits by intravenous injection throughout organogenesis, no adverse effects on embryofetal development were observed. The higher dose tested (150 mg/kg) is 30 times the maximum recommended human dose (MRHD) of 300 mg, on a body weight basis (mg/kg). When eptinezumab-jjmr (0, 75, or 150 mg/kg) was administered weekly to female rats throughout pregnancy and lactation, no adverse effects on pre- and postnatal development were observed. The higher dose tested (150 mg/kg) is 30 times the MRHD, on a mg/kg basis."],"description":["11 DESCRIPTION Eptinezumab-jjmr is a humanized immunoglobulin G1 (IgG1) monoclonal antibody specific for calcitonin gene-related peptide (CGRP) ligand. Eptinezumab-jjmr has an approximate molecular weight of 143 kD. Eptinezumab-jjmr is produced in Pichia pastoris yeast cells by recombinant DNA technology. VYEPTI (eptinezumab-jjmr) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to brownish-yellow solution, for intravenous infusion. VYEPTI is supplied as a 100 mg/mL single-dose vial. Each mL contains 100 mg eptinezumab-jjmr formulated in L-histidine (1 mg), L-histidine hydrochloride monohydrate (2.8 mg), polysorbate 80 (0.15 mg), sorbitol (40.5 mg), and Water for Injection, USP, at a pH of 5.8."],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied VYEPTI (eptinezumab-jjmr) injection is a clear to slightly opalescent, colorless to brownish-yellow solution supplied as: Carton containing one 100 mg/mL single-dose vial - NDC 67386-130-51. 16.2 Storage and Handling Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use. Do not freeze or shake. The vial stopper is not made with natural rubber latex."],"geriatric_use":["8.5 Geriatric Use Clinical studies of VYEPTI did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients."],"pediatric_use":["8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established."],"effective_time":"20251022","clinical_studies":["14 CLINICAL STUDIES The efficacy of VYEPTI was evaluated in three randomized, multicenter, placebo-controlled double-blind studies that enrolled patients with episodic and chronic migraine who were eligible for preventive treatment of migraine. In Study 1, which included patients with episodic migraine, and Study 2, which included patients with chronic migraine, either 100 mg or 300 mg VYEPTI was administered by intravenous infusion every 3 months. In Study 3, 100 mg VYEPTI was administered as a single intravenous infusion to patients with episodic or chronic migraine who were eligible for preventive migraine treatment and who had a concurrent migraine. Study 1: Episodic Migraine Study 1 (NCT02559895) included adults with a history of episodic migraine (4 to 14 headache days per month, of which at least 4 were migraine days). A total of 665 patients were randomized to receive placebo (N=222), 100 mg VYEPTI (N=221), or 300 mg VYEPTI (N=222) every 3 months for 12 months. Patients were allowed to use concurrent acute migraine or headache medications, including migraine-specific medications (i.e., triptans, ergotamine derivatives), during the trial. The study excluded patients with a history of cardiovascular disease (hypertension, ischemic heart disease), neurological disease, or cerebrovascular disease. The primary efficacy endpoint was the change from baseline in mean monthly migraine days over Months 1-3. Secondary endpoints included the percentages of patients with 50% or greater, and 75% or greater reductions from baseline in monthly migraine days over Months 1-3. Patients had a median age of 39 years (range: 18 to 71 years), 84% were female, and 84% were white. The mean migraine frequency at baseline was approximately 8.6 migraine days per month and was similar across treatment groups. VYEPTI treatment demonstrated statistically significant improvements compared to placebo for the primary efficacy endpoint, as shown in Table 2; secondary endpoints are also summarized in Table 2. Table 2. Efficacy Endpoint Results in Study 1 VYEPTI 100 mg N=221 VYEPTI 300 mg N=222 Placebo N=222 Monthly Migraine Days (MMD) – Months 1-3 Change from baseline -3.9 -4.3 -3.2 Difference from placebo -0.7 -1.1 p -value 0.018 <0.001 ≥50% MMD responders – Months 1-3 % Responders 49.8% 56.3% 37.4% Difference from placebo 12.4% 18.9% p - value 0.009* <0.001 ≥75% MMD responders – Months 1-3 % Responders 22.2% 29.7% 16.2% Difference from placebo 6.0% 13.5% p -value NS** <0.001 * Nominal statistical significance ** NS = Not statistically significant Figure 1 shows the mean change from baseline in average monthly migraine days in Study 1. Patients treated with VYEPTI at both doses had greater mean decreases from baseline in mean monthly migraine days over Months 1-3 compared to placebo-treated patients. Figure 1. Change from Baseline in Monthly Migraine Days in Study 1 Figure 2 shows the distribution of change from baseline in mean monthly migraine days through Month 3 by treatment group in 2-day increments. Figure 2. Distribution of Change from Baseline in Mean Monthly Migraine Days over Months 1 to 3 by Treatment Group in Study 1 Figure 3 demonstrates that greater percentages of placebo-treated patients had migraines on most days during the first 7 days of treatment compared to VYEPTI-treated patients in Study 1. Figure 3. Percentage of Patients with a Migraine from Day -1 (Day Prior to Infusion) to Day 7 in Study 1 Study 2: Chronic Migraine Study 2 (NCT02974153) included adults with a history of chronic migraine (15 to 26 headache days per month, of which at least 8 were migraine days). A total of 1072 patients were randomized and received placebo (N=366), 100 mg VYEPTI (N=356), or 300 mg VYEPTI (N=350) every 3 months for 6 months. Patients were allowed to use and to continue an established stable regimen of acute migraine or headache preventive medication (except onabotulinumtoxinA). Patients with a dual diagnosis of chronic migraine and medication overuse headache attributable to acute medication overuse (triptans, ergotamine, or combination analgesics greater than 10 days per month) were included in the study population. Patients using opioids or butalbital-containing products greater than 4 days per month were not allowed. The study excluded patients with a history of cardiovascular disease (hypertension, ischemic heart disease), neurological disease, or cerebrovascular disease. The primary efficacy endpoint was the change from baseline in mean monthly migraine days over Months 1-3. Secondary endpoints included the percentages of patients with 50% or greater and 75% or greater reductions from baseline in monthly migraine days over Months 1-3. Patients had a median age of 41 years (range: 18 to 65 years), 88% were female, and 91% were white. Forty-one percent of patients were taking concomitant preventive medication for migraine. The mean migraine frequency at baseline was approximately 16.1 migraine days per month and was similar across treatment groups. VYEPTI treatment demonstrated statistically significant improvements compared to placebo for the primary efficacy endpoint, as shown in Table 3; secondary endpoints are also summarized in Table 3. Table 3. Efficacy Endpoint Results in Study 2 VYEPTI100 mg N=356 VYEPTI300 mg N=350 Placebo N=366 Monthly Migraine Days (MMD) – Months 1-3 Change from baseline -7.7 -8.2 -5.6 Difference from placebo -2.0 -2.6 p- value <0.001 <0.001 ≥50% MMD responders –Months 1-3 % Responders 57.6% 61.4% 39.3% Difference from placebo 18.2% 22.1% p - value <0.001 <0.001 ≥75% MMD responders –Months 1-3 % Responders 26.7% 33.1% 15.0% Difference from placebo 11.7% 18.1% p -value <0.001 <0.001 Figure 4 shows the mean change from baseline in average monthly migraine days for Study 2. Patients treated with VYEPTI at both doses had greater mean decreases from baseline in mean monthly migraine days over Month 1-3 compared to placebo-treated patients. Figure 4. Change from Baseline in Monthly Migraine Days in Study 2 Figure 5 shows the distribution of change from baseline in mean monthly migraine days through Month 3 by treatment group in 3-day increments. Figure 5. Distribution of Change from Baseline in Mean Monthly Migraine Days over Months 1-3 by Treatment Group in Study 2 Figure 6 demonstrates that greater percentages of placebo-treated patients had migraines on individual days during the first 7 days of treatment compared to VYEPTI-treated patients in Study 2. Figure 6. Percentage of Patients with a Migraine from Day -1 (Day Prior to Infusion) to Day 7 in Study 2 Study 3: Episodic Migraine or Chronic Migraine Study 3 (NCT01719055) included adults who were candidates for preventive migraine therapy with VYEPTI and presented with a concurrent moderate to severe migraine on the day of infusion. A total of 480 patients were randomized to receive 100 mg VYEPTI (n=238) or placebo (n=242) as a single dose. VYEPTI demonstrated statistically significant improvements in headache pain freedom at 2 hours (VYEPTI 23.5% vs placebo 12%; p<0.001) and absence of most bothersome symptom (such as nausea, photophobia, or phonophobia) at 2 hours (VYEPTI 55.5% vs placebo 35.8%; p< 0.001) as compared to placebo. The dose of 300 mg VYEPTI was not evaluated in Study 3. Figure 1. Change from Baseline in Monthly Migraine Days in Study 1 Figure 2. Distribution of Change from Baseline in Mean Monthly Migraine Days over Months 1 to 3 by Treatment Group in Study 1 Figure 3. Percentage of Patients with a Migraine from Day -1 (Day Prior to Infusion) to Day 7 in Study 1 Figure 4. Change from Baseline in Monthly Migraine Days in Study 2 Figure 5. Distribution of Change from Baseline in Mean Monthly Migraine Days over Months 1-3 by Treatment Group in Study 2 Figure 6. Percentage of Patients with a Migraine from Day -1 (Day Prior to Infusion) to Day 7 in Study 2"],"pharmacodynamics":["12.2 Pharmacodynamics The relationship between the pharmacodynamic activity and the mechanism(s) by which eptinezumab-jjmr exerts its clinical effects is unknown."],"pharmacokinetics":["12.3 Pharmacokinetics Eptinezumab-jjmr exhibits linear pharmacokinetics and exposure increases proportionally with doses from 100 mg to 300 mg after intravenous administration. Steady-state plasma concentration is attained after the first dose with a once every 3-month dosing schedule. Distribution The central volume of distribution (Vc) for eptinezumab-jjmr is approximately 3.7 liters. Metabolism & Elimination Eptinezumab-jjmr is expected to be degraded by proteolytic enzymes into small peptides and amino acids. The apparent clearance of eptinezumab-jjmr was 0.006 L/h, and the terminal elimination half-life was approximately 27 days. Specific Populations A population pharmacokinetic analysis assessing the effects of age, race, sex, and body weight did not suggest any clinically significant impact of these covariates on eptinezumab exposures. Patients with Renal or Hepatic Impairment No dedicated studies were conducted to assess the effects of renal or hepatic impairment on the pharmacokinetics of eptinezumab-jjmr. However, hepatic or renal impairment is not expected to affect the pharmacokinetics of eptinezumab-jjmr. A population pharmacokinetic analysis of integrated data from eptinezumab-jjmr clinical studies did not reveal clinically significant impact on pharmacokinetics of patients with hepatic or renal impairment. Drug Interaction Studies P450 Enzymes Eptinezumab-jjmr is not metabolized by cytochrome P450 enzymes; therefore, interactions with concomitant medications that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely. Sumatriptan The co-administration of a single dose of 300 mg eptinezumab-jjmr administered as an intravenous infusion (over a period of 1 hour ± 15 min) with a single dose of 6 mg sumatriptan administered subcutaneously did not significantly influence the pharmacokinetics of eptinezumab-jjmr or sumatriptan."],"adverse_reactions":["6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] . Hypertension [see Warnings and Precautions (5.2) ] Raynaud’s Phenomenon [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥2% and 2% or greater than placebo) were nasopharyngitis and hypersensitivity ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck at 1-800-455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of VYEPTI was evaluated in 2076 patients with migraine who received at least one dose of VYEPTI, representing 1615 patient-years of exposure; of these, 1524 patients were exposed to 100 mg or 300 mg. Across all doses, 1872 patients were exposed for at least 6 months and 991 patients were exposed for 12 months. In the placebo-controlled clinical studies (Study 1 and Study 2) of 1372 patients, 579 patients received at least one dose of VYEPTI 100 mg, 574 patients received at least one dose of VYEPTI 300 mg, and 588 patients received placebo [see Clinical Studies (14) ] . Approximately 86% were female, 89% were white, and the mean age was 40.4 years at study entry. The most common (incidence at least 2% and at least 2% greater than placebo) adverse reactions in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. Table 1 summarizes the adverse reactions that occurred during Study 1 and Study 2. Table 1. Adverse Reactions Occurring with an Incidence of at Least 2% for VYEPTI and at Least 2% Greater than Placebo in Studies 1 and 2 Adverse Reactions VYEPTI 100 mg N=579% VYEPTI 300 mg N=574% Placebo N=588% Nasopharyngitis 6 8 6 Hypersensitivity reactions* 1 2 0 * Hypersensitivity reactions includes multiple related adverse event terms, such as hypersensitivity, pruritus, and flushing/hot flush that occurred on the day of dosing. In Study 1 and Study 2, 1.9% of patients treated with VYEPTI discontinued treatment because of adverse reactions [see Warnings and Precautions (5.1) ] . In study 3, the safety profile observed in 480 patients who were randomized and treated (238 to VYEPTI 100 mg and 242 to placebo) was consistent with the safety profile observed in the two pivotal placebo-controlled studies with VYEPTI (Study 1 and 2). 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of VYEPTI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders: Anaphylaxis [see Contraindications (4) and Warnings and Precautions (5.1) ] General Disorders and Administration Site Conditions: Fatigue Vascular Disorders: Hypertension [see Warnings and Precautions (5.2) ] , Raynaud’s phenomenon [see Warnings and Precautions (5.3) ]"],"contraindications":["4 CONTRAINDICATIONS VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients in VYEPTI. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.1) ] . VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients ( 4)"],"mechanism_of_action":["12.1 Mechanism of Action Eptinezumab-jjmr is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor."],"recent_major_changes":["Warnings and Precautions ( 5.2 , 5.3 ) 3/2025"],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Eptinezumab-jjmr is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor. 12.2 Pharmacodynamics The relationship between the pharmacodynamic activity and the mechanism(s) by which eptinezumab-jjmr exerts its clinical effects is unknown. 12.3 Pharmacokinetics Eptinezumab-jjmr exhibits linear pharmacokinetics and exposure increases proportionally with doses from 100 mg to 300 mg after intravenous administration. Steady-state plasma concentration is attained after the first dose with a once every 3-month dosing schedule. Distribution The central volume of distribution (Vc) for eptinezumab-jjmr is approximately 3.7 liters. Metabolism & Elimination Eptinezumab-jjmr is expected to be degraded by proteolytic enzymes into small peptides and amino acids. The apparent clearance of eptinezumab-jjmr was 0.006 L/h, and the terminal elimination half-life was approximately 27 days. Specific Populations A population pharmacokinetic analysis assessing the effects of age, race, sex, and body weight did not suggest any clinically significant impact of these covariates on eptinezumab exposures. Patients with Renal or Hepatic Impairment No dedicated studies were conducted to assess the effects of renal or hepatic impairment on the pharmacokinetics of eptinezumab-jjmr. However, hepatic or renal impairment is not expected to affect the pharmacokinetics of eptinezumab-jjmr. A population pharmacokinetic analysis of integrated data from eptinezumab-jjmr clinical studies did not reveal clinically significant impact on pharmacokinetics of patients with hepatic or renal impairment. Drug Interaction Studies P450 Enzymes Eptinezumab-jjmr is not metabolized by cytochrome P450 enzymes; therefore, interactions with concomitant medications that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely. Sumatriptan The co-administration of a single dose of 300 mg eptinezumab-jjmr administered as an intravenous infusion (over a period of 1 hour ± 15 min) with a single dose of 6 mg sumatriptan administered subcutaneously did not significantly influence the pharmacokinetics of eptinezumab-jjmr or sumatriptan. 12.6 Immunogenicity The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of eptinezumab-jjmr. In patients receiving VYEPTI 100 mg or 300 mg every 3 months, the incidence of anti-eptinezumab-jjmr antibody development in Study 1 (up to 56 weeks) was 20.6% (92/447), and 41.3% (38/92) of those patients developed anti-eptinezumab-jjmr neutralizing antibodies. In Study 2 (up to 32 weeks), the incidence of anti-eptinezumab-jjmr antibody development was 18.3% (129/706), and 34.9% (45/129) of those patients developed anti-eptinezumab-jjmr neutralizing antibodies. In an open-label study with 84 weeks of treatment, 18% (23/128) of patients developed anti-eptinezumab-jjmr antibodies, and 39% (9/23) of those patients developed anti-eptinezumab-jjmr neutralizing antibodies. Although the results from both studies showed no clear evidence of an impact from development of anti-eptinezumab-jjmr antibodies, including neutralizing antibodies, on the safety and efficacy profiles of VYEPTI, the available data are too limited to make definitive conclusions."],"indications_and_usage":["1 INDICATIONS AND USAGE VYEPTI is indicated for the preventive treatment of migraine in adults. VYEPTI is a calcitonin gene-related peptide antagonist indicated for the preventive treatment of migraine in adults ( 1 )"],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: If a hypersensitivity reaction occurs, consider discontinuing VYEPTI and initiate appropriate therapy ( 5.1 ) Hypertension: New-onset or worsening of pre-existing hypertension may occur ( 5.2 ) Raynaud’s Phenomenon: New-onset or worsening of pre-existing Raynaud’s phenomenon may occur ( 5.3 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions, including angioedema, urticaria, facial flushing, dyspnea, and rash, have occurred with VYEPTI in clinical trials and in the postmarketing setting. Most hypersensitivity reactions occurred during infusion and were not serious, but often led to discontinuation or required treatment. Serious hypersensitivity reactions may occur. Cases of anaphylaxis have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing VYEPTI and institute appropriate therapy [see Contraindications (4) and Patient Counseling Information (17) ] . 5.2 Hypertension Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including VYEPTI, in the postmarketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension, and in some cases hospitalization. Hypertension may occur at any time during treatment, but was most frequently reported within 7 days of therapy initiation. The CGRP antagonist was discontinued in many of the reported cases. Monitor patients treated with VYEPTI for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of VYEPTI is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled. 5.3 Raynaud’s Phenomenon Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists. In reported cases with monoclonal antibody CGRP antagonists, symptom onset occurred a median of 71 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most reported cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms. VYEPTI should be discontinued if signs or symptoms of Raynaud’s phenomenon develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms."],"clinical_studies_table":["
VYEPTI 100 mg N=221VYEPTI 300 mg N=222Placebo N=222
Monthly Migraine Days (MMD) – Months 1-3
Change from baseline -3.9-4.3 -3.2
Difference from placebo -0.7 -1.1
p-value 0.018 <0.001
≥50% MMD responders – Months 1-3
% Responders 49.8% 56.3% 37.4%
Difference from placebo 12.4% 18.9%
p-value0.009* <0.001
≥75% MMD responders – Months 1-3
% Responders 22.2% 29.7% 16.2%
Difference from placebo 6.0% 13.5%
p-value NS** <0.001
","
VYEPTI100 mg N=356VYEPTI300 mg N=350Placebo N=366
Monthly Migraine Days (MMD) – Months 1-3
Change from baseline-7.7-8.2-5.6
Difference from placebo-2.0-2.6
p-value<0.001<0.001
≥50% MMD responders –Months 1-3
% Responders57.6%61.4%39.3%
Difference from placebo18.2%22.1%
p-value<0.001 <0.001
≥75% MMD responders –Months 1-3
% Responders26.7%33.1%15.0%
Difference from placebo11.7%18.1%
p-value<0.001<0.001
"],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis The carcinogenic potential of eptinezumab-jjmr has not been assessed. Mutagenesis Genetic toxicology studies of eptinezumab-jjmr have not been conducted. Impairment of Fertility When eptinezumab-jjmr (0, 75, or 150 mg/kg) was administered weekly by intravenous injection to male and female rats prior to and during mating and continuing in females to gestation day 3-4, no adverse effects on fertility were observed. The higher dose tested (150 mg/kg) is 30 times the maximum recommended human dose of 300 mg, on a body weight basis (mg/kg)."],"adverse_reactions_table":["
Adverse ReactionsVYEPTI 100 mg N=579%VYEPTI 300 mg N=574%Placebo N=588%
Nasopharyngitis686
Hypersensitivity reactions*120
"],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Hypersensitivity Reactions Inform patients about the signs and symptoms of hypersensitivity reactions and that these reactions can occur with VYEPTI. Advise patients to contact their healthcare provider immediately if signs or symptoms of hypersensitivity reactions occur [see Warnings and Precautions (5.1) ] . Hypertension Inform patients that hypertension can develop or pre-existing hypertension can worsen with VYEPTI, and that they should contact their healthcare provider if they experience elevation in their blood pressure [see Warnings and Precautions (5.2) ] . Raynaud’s Phenomenon Inform patients that Raynaud’s phenomenon can develop or worsen with VYEPTI. Advise patients to discontinue VYEPTI treatment and contact their healthcare provider if they experience signs or symptoms of Raynaud’s phenomenon [see Warnings and Precautions (5.3) ] . Pregnancy Exposure Registry Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VYEPTI during pregnancy [see Use in Specific Populations (8.1) ] . Lactation Inform patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations (8.2) ] . Manufactured by: Lundbeck Seattle BioPharmaceuticals, Inc. 11804 North Creek Parkway South Bothell, WA 98011 USA U.S. License No. 2097 Vyepti is a registered trademark of Lundbeck Seattle BioPharmaceuticals, Inc. Lundbeck logo"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION Must dilute before use. For intravenous infusion only ( 2.1 , 2.2 ) Recommended dosage is 100 mg as an intravenous infusion over approximately 30 minutes every 3 months. Some patients may benefit from a dosage of 300 mg every 3 months ( 2.1 , 2.3 ) Dilute only in 100 mL of 0.9% Sodium Chloride Injection ( 2.2 ) 2.1 Recommended Dosing The recommended dosage is 100 mg administered by intravenous infusion every 3 months. Some patients may benefit from a dosage of 300 mg administered by intravenous infusion every 3 months. 2.2 Dilution Instructions VYEPTI requires dilution prior to administration. Dilute only in 100 mL 0.9% Sodium Chloride Injection, USP. The infusion bags must be made of polyvinyl chloride (PVC), polyethylene (PE), or polyolefin (PO). Use appropriate aseptic technique when preparing VYEPTI solution for intravenous infusion. VYEPTI single-dose vials contain no preservative; discard unused portion remaining in the vial. Dilution 100 mg dose: To prepare the solution, withdraw 1 mL of VYEPTI from a single-dose vial using a sterile needle and syringe. Inject the 1 mL content into a 100 mL bag of 0.9% Sodium Chloride Injection, USP. 300 mg dose: To prepare the solution, withdraw 1 mL of VYEPTI from each of 3 single-dose vials using a sterile needle and syringe. Inject the resulting 3 mL content into a 100 mL bag of 0.9% Sodium Chloride Injection, USP. Storage and Handling of Diluted Product Gently invert the VYEPTI solution to mix completely. Do not shake. Following dilution, VYEPTI solution must be infused within 8 hours. During this time, VYEPTI solution should be stored at room temperature, 20°C to 25°C (68°F to 77°F). Do not freeze. 2.3 Infusion Administration Instructions Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the liquid contains visible particulate matter or is cloudy or discolored [see Dosage Forms and Strengths (3) ] . No other medications should be administered through the infusion set or mixed with VYEPTI. VYEPTI is for intravenous infusion only; infuse over approximately 30 minutes. Do not administer VYEPTI as an intravenous push or bolus injection. Use an intravenous infusion set with a 0.2 micron or 0.22 micron in-line or add-on sterile filter. After the infusion is complete, flush the line with 20 mL of 0.9% Sodium Chloride Injection, USP."],"spl_product_data_elements":["Vyepti eptinezumab-jjmr EPTINEZUMAB EPTINEZUMAB HISTIDINE HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE POLYSORBATE 80 SORBITOL WATER"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS VYEPTI is a clear to slightly opalescent, colorless to brownish-yellow solution available as follows: Injection: 100 mg/mL in a single-dose vial Injection: 100 mg/mL solution in a single-dose vial ( 3 )"],"spl_patient_package_insert":["PATIENT PACKAGE INSERT PATIENT INFORMATION VYEPTI ® (vye ep' tee) (eptinezumab-jjmr) injection, for intravenous use What is VYEPTI? VYEPTI is a prescription medicine used for the preventive treatment of migraine in adults. It is not known if VYEPTI is safe and effective in children. Do not receive VYEPTI if you are allergic to eptinezumab-jjmr or any of the ingredients in VYEPTI. See the end of this Patient Information leaflet for a complete list of ingredients in VYEPTI. Before you receive VYEPTI, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure. have circulation problems in your fingers and toes. are pregnant or plan to become pregnant. It is not known if VYEPTI will harm your unborn baby. Pregnancy Registry : There is a pregnancy registry for women who take VYEPTI. The purpose of this registry is to collect information about the health of you and your baby. You may enroll yourself by calling 1-855-810-8549 or by visiting www.vyeptipregnancyregistry.lundbeck.com . Or you may talk to your healthcare provider about how you can take part in this registry. are breastfeeding or plan to breastfeed. It is not known if VYEPTI passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using VYEPTI. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. How will I receive VYEPTI? VYEPTI will be given by a healthcare provider in a healthcare setting. VYEPTI is given by intravenous (IV) infusion in your vein. VYEPTI will be given over 30 minutes every 3 months. If you have questions about your infusion schedule, ask your healthcare provider. What are the possible side effects of VYEPTI? VYEPTI may cause serious side effects, including: Allergic reactions. Allergic reactions can happen after receiving VYEPTI. Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms of an allergic reaction: o rash o swelling of your face, lips, tongue or throat o trouble breathing o hives o redness in your face High blood pressure. High blood pressure or worsening of high blood pressure can happen after receiving VYEPTI. Contact your healthcare provider if you have an increase in blood pressure. Raynaud’s phenomenon. A type of circulation problem can worsen or happen after receiving VYEPTI. Raynaud’s phenomenon can lead to your fingers or toes feeling numb, cool, or painful, or changing color from pale, to blue, to red. Contact your healthcare provider if these symptoms occur. The most common side effects of VYEPTI include: stuffy nose and scratchy throat allergic reactions These are not all of the possible side effects of VYEPTI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. General information about the safe and effective use of VYEPTI. Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about VYEPTI that is written for health professionals. What are the ingredients in VYEPTI? Active ingredient : eptinezumab-jjmr Inactive ingredients : L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sorbitol, and Water for Injection. The vial stopper is not made with natural rubber latex. Manufactured by: Lundbeck Seattle BioPharmaceuticals, Inc., 11804 North Creek Parkway South, Bothell, WA 98011 US License Number: 2097 Vyepti is a registered trademark of Lundbeck Seattle BioPharmaceuticals, Inc. For more information, call 1-833-4-VYEPTI (833-489-3784) or go to www.Vyepti.com This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 10/2025 Lundbeck logo"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VYEPTI during pregnancy. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-855-810-8549 or by contacting the company at www.vyeptipregnancyregistry.lundbeck.com. Risk Summary There are no adequate data on developmental risks associated with the use of VYEPTI in pregnant women. No adverse developmental effects were observed following administration of eptinezumab-jjmr to pregnant animals at doses greater than those used clinically [see Data] . In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. The estimated rate of major birth defects (2.2%-2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy. Data Animal Data When eptinezumab-jjmr (0, 75, or 150 mg/kg) was administered weekly to female rats and rabbits by intravenous injection throughout organogenesis, no adverse effects on embryofetal development were observed. The higher dose tested (150 mg/kg) is 30 times the maximum recommended human dose (MRHD) of 300 mg, on a body weight basis (mg/kg). When eptinezumab-jjmr (0, 75, or 150 mg/kg) was administered weekly to female rats throughout pregnancy and lactation, no adverse effects on pre- and postnatal development were observed. The higher dose tested (150 mg/kg) is 30 times the MRHD, on a mg/kg basis. 8.2 Lactation Risk Summary There are no data on the presence of eptinezumab-jjmr in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VYEPTI and any potential adverse effects on the breastfed infant from VYEPTI or from the underlying maternal condition. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use Clinical studies of VYEPTI did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients."],"spl_patient_package_insert_table":["
PATIENT INFORMATIONVYEPTI®(vye ep' tee)(eptinezumab-jjmr)injection, for intravenous use
What is VYEPTI?VYEPTI is a prescription medicine used for the preventive treatment of migraine in adults.It is not known if VYEPTI is safe and effective in children.
Do not receive VYEPTI if you are allergic to eptinezumab-jjmr or any of the ingredients in VYEPTI. See the end of this Patient Information leaflet for a complete list of ingredients in VYEPTI.
Before you receive VYEPTI, tell your healthcare provider about all of your medical conditions, including if you:have high blood pressure.have circulation problems in your fingers and toes.are pregnant or plan to become pregnant. It is not known if VYEPTI will harm your unborn baby. Pregnancy Registry: There is a pregnancy registry for women who take VYEPTI. The purpose of this registry is to collect information about the health of you and your baby. You may enroll yourself by calling 1-855-810-8549 or by visiting www.vyeptipregnancyregistry.lundbeck.com. Or you may talk to your healthcare provider about how you can take part in this registry.are breastfeeding or plan to breastfeed. It is not known if VYEPTI passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using VYEPTI.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive VYEPTI?VYEPTI will be given by a healthcare provider in a healthcare setting. VYEPTI is given by intravenous (IV) infusion in your vein.VYEPTI will be given over 30 minutes every 3 months. If you have questions about your infusion schedule, ask your healthcare provider.
What are the possible side effects of VYEPTI?VYEPTI may cause serious side effects, including:Allergic reactions. Allergic reactions can happen after receiving VYEPTI. Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms of an allergic reaction: o rasho swelling of your face, lips, tongue or throat o trouble breathingo hiveso redness in your faceHigh blood pressure. High blood pressure or worsening of high blood pressure can happen after receiving VYEPTI. Contact your healthcare provider if you have an increase in blood pressure. Raynaud’s phenomenon. A type of circulation problem can worsen or happen after receiving VYEPTI. Raynaud’s phenomenon can lead to your fingers or toes feeling numb, cool, or painful, or changing color from pale, to blue, to red. Contact your healthcare provider if these symptoms occur.The most common side effects of VYEPTI include:stuffy nose and scratchy throatallergic reactionsThese are not all of the possible side effects of VYEPTI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of VYEPTI.Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet.You can ask your pharmacist or healthcare provider for information about VYEPTI that is written for health professionals.
What are the ingredients in VYEPTI?Active ingredient: eptinezumab-jjmrInactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sorbitol, and Water for Injection.The vial stopper is not made with natural rubber latex. Manufactured by: Lundbeck Seattle BioPharmaceuticals, Inc., 11804 North Creek Parkway South, Bothell, WA 98011US License Number: 2097
Vyepti is a registered trademark of Lundbeck Seattle BioPharmaceuticals, Inc. For more information, call 1-833-4-VYEPTI (833-489-3784) or go to www.Vyepti.com
"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 67386-130-51 VYEPTITM (vye ep' tee) (eptinezumab-jjmr) injection, for intravenous use 100 mg/mL NDC 67386-130-51 VYEPTITM (vye ep' tee) (eptinezumab-jjmr) injection, for intravenous use 100 mg/mL injection, for intravenous use 100 mg/mL","PRINCIPAL DISPLAY PANEL NDC 67386-130-91 VYEPTITM (vye ep' tee) (eptinezumab-jjmr) injection, for intravenous use 100 mg/mL Professional Sample Professional Sample NDC 67386-130-91 VYEPTITM (vye ep' tee) (eptinezumab-jjmr) njection, for intravenous use 100 mg/mL Professional Sample"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis The carcinogenic potential of eptinezumab-jjmr has not been assessed. Mutagenesis Genetic toxicology studies of eptinezumab-jjmr have not been conducted. Impairment of Fertility When eptinezumab-jjmr (0, 75, or 150 mg/kg) was administered weekly by intravenous injection to male and female rats prior to and during mating and continuing in females to gestation day 3-4, no adverse effects on fertility were observed. The higher dose tested (150 mg/kg) is 30 times the maximum recommended human dose of 300 mg, on a body weight basis (mg/kg)."]},"tags":[{"label":"Calcitonin Gene-related Peptide Antagonist","category":"class"},{"label":"Monoclonal Antibody","category":"modality"},{"label":"Calcitonin gene-related peptide 1","category":"target"},{"label":"CALCA","category":"gene"},{"label":"CALCB","category":"gene"},{"label":"N02CD05","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Injection","category":"form"},{"label":"Active","category":"status"},{"label":"Migraine","category":"indication"},{"label":"Prevention of migraine attacks","category":"indication"},{"label":"Lundbeck Seattle BioPharmaceuticals, Inc.","category":"company"},{"label":"Approved 2020s","category":"decade"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"1954 reports"},{"date":"","signal":"MIGRAINE","source":"FDA FAERS","actionTaken":"1366 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"903 reports"},{"date":"","signal":"THERAPEUTIC RESPONSE SHORTENED","source":"FDA FAERS","actionTaken":"511 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"500 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"453 reports"},{"date":"","signal":"DRUG EFFECT LESS THAN EXPECTED","source":"FDA FAERS","actionTaken":"337 reports"},{"date":"","signal":"THROAT IRRITATION","source":"FDA FAERS","actionTaken":"322 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"308 reports"},{"date":"","signal":"PRURITUS","source":"FDA FAERS","actionTaken":"284 reports"}],"commonSideEffects":[{"effect":"Nasopharyngitis","drugRate":"6.1%","severity":"common","_validated":true},{"effect":"Hypersensitivity reactions","drugRate":"6.1%","severity":"common","_validated":true},{"effect":"Anaphylaxis","drugRate":"reported","severity":"serious"},{"effect":"Anti-eptinezumab-jjmr antibody development","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Anti-eptinezumab-jjmr neutralizing antibodies","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3}],"specialPopulations":{"Lactation":"There are no data on the presence of eptinezumab-jjmr in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for VYEPTI and any potential adverse effects on the breastfed infant from VYEPTI or from the underlying maternal condition.","Pregnancy":"There are no adequate data on developmental risks associated with the use of VYEPTI in pregnant women.No adverse developmental effects were observed following administration of eptinezumab-jjmr to pregnant animals at doses greater than those used clinically [see Data]. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. The estimated rate of major birth defects (2.2%-2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine.Clinical ConsiderationsDisease-Associated Maternal and/or Embryo/Fetal RiskPublished data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy.","Geriatric use":"Clinical studies of VYEPTI did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.","Paediatric use":"Safety and effectiveness in pediatric patients have not been established."}},"trials":[],"aliases":[],"company":"Lundbeck Seattle BioPharmaceuticals, Inc.","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=EPTINEZUMAB","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T02:04:32.446154+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Eptinezumab","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T02:04:40.826319+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T02:04:39.482793+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T02:04:32.463763+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T02:04:28.079135+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=EPTINEZUMAB","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T02:04:40.249506+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:04:27.101784+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:04:27.101807+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:04:27.101812+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T02:04:41.758486+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Calcitonin gene-related peptide inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T02:04:40.825991+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3833320/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T02:04:40.722482+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"BLA761119","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:04:27.101815+00:00"}},"allNames":"vyepti","offLabel":[],"synonyms":["eptinezumab","eptinezumab-jjmr","vyepti","ALD403"],"timeline":[{"date":"2020-02-21","type":"positive","source":"DrugCentral","milestone":"FDA approval (Lundbeck Seattle BioPharmaceuticals, Inc.)"},{"date":"2022-01-24","type":"positive","source":"DrugCentral","milestone":"EMA approval (H. Lundbeck A/S)"}],"approvals":[{"date":"2020-02-21","orphan":false,"company":"Lundbeck Seattle BioPharmaceuticals, Inc.","regulator":"FDA"},{"date":"2022-01-24","orphan":false,"company":"H. LUNDBECK A/S","regulator":"EMA"}],"brandName":"Vyepti","ecosystem":[{"indication":"Migraine","otherDrugs":[{"name":"acetylsalicylic acid","slug":"acetylsalicylic-acid","company":"Endo Pharms"},{"name":"almotriptan","slug":"almotriptan","company":"Janssen Pharms"},{"name":"caffeine","slug":"caffeine","company":"Novartis"},{"name":"dihydroergotamine","slug":"dihydroergotamine","company":"Valeant"}],"globalPrevalence":1000000000},{"indication":"Prevention of migraine attacks","otherDrugs":[{"name":"erenumab","slug":"erenumab","company":"Amgen Inc"},{"name":"fremanezumab","slug":"fremanezumab","company":"Teva Pharms Usa"},{"name":"rimegepant","slug":"rimegepant","company":"Biohaven Pharm"}],"globalPrevalence":1000000000}],"mechanism":{"target":"Calcitonin gene-related peptide 1","novelty":"Follow-on","targets":[{"gene":"CALCA","source":"DrugCentral","target":"Calcitonin gene-related peptide 1","protein":"Calcitonin gene-related peptide 1"},{"gene":"CALCB","source":"DrugCentral","target":"Calcitonin gene-related peptide 2","protein":"Calcitonin gene-related peptide 2"}],"moaClass":"Calcitonin Gene-related Peptide Antagonists","modality":"Monoclonal Antibody","drugClass":"Calcitonin Gene-related Peptide Antagonist [EPC]","explanation":"Eptinezumab-jjmr is humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.","oneSentence":"Vyepti works by blocking the action of calcitonin gene-related peptide 1, a molecule involved in migraine pain.","technicalDetail":"Vyepti (eptinezumab) is a calcitonin gene-related peptide 1 (CGRP1) antagonist that selectively binds to the CGRP1 receptor, preventing the binding of endogenous CGRP1 and thereby inhibiting the activation of CGRP1-mediated pathways involved in migraine pathophysiology."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Eptinezumab","title":"Eptinezumab","extract":"Eptinezumab, sold under the brand name Vyepti, is a medication used for the preventive treatment of migraine in adults. It is a monoclonal antibody that targets calcitonin gene-related peptides (CGRP) alpha and beta. It is administered by intravenous infusion.","wiki_history":"== History ==\nThe US Food and Drug Administration (FDA) approved eptinezumab based primarily on evidence from two clinical trials (Trial 1/NCT02559895 and Trial 2/NCT02974153) of 1741 participants with chronic or episodic migraine headaches. Trials were conducted at 212 sites in United States, Georgia, Russia, Ukraine and the European Union. The benefit and side effects of eptinezumab were evaluated in two clinical trials of adults aged 18 through 71 years of age with a history of migraine headaches. The trials had similar designs.\n\nTrial 1 enrolled participants with a history of episodic migraine headaches and Trial 2 enrolled participants with chronic migraine headaches. Participants were assigned to receive one of two doses of eptinezumab or placebo injections every three months for a total of twelve months in Trial 1, and for a total of 6 months in Trial 2. Neither the participants nor the health care providers knew which treatment was being given until the trial was completed. The benefit of eptinezumab in comparison to placebo was assessed based on the change in the number of migraine days per month during the first three-month treatment period.","wiki_society_and_culture":"== Society and culture ==\n=== Legal status ===\nEptinezumab was approved for medical use in the United States in February 2020. The applicant for this medicinal product is H. Lundbeck A/S.\n\n=== Names ===\nEptinezumab is the international nonproprietary name.\n\nIt is sold under the brand name Vyepti."},"commercial":{"launchDate":"2020","revenueYear":2024,"_launchSource":"DrugCentral (FDA 2020-02-21, Lundbeck Seattle BioPharmaceuticals, Inc.)","annualRevenue":300,"revenueSource":"Lundbeck FY2024 (Vyepti)","revenueCurrency":"USD"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5386","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=EPTINEZUMAB","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=EPTINEZUMAB","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Eptinezumab","fields":["history","overview"],"source":"Wikipedia"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T11:04:42.656247","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T02:04:45.945907+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"erenumab","drugSlug":"erenumab","fdaApproval":"2018-05-17","relationship":"same-class"},{"drugName":"galcanezumab","drugSlug":"galcanezumab","fdaApproval":"2018-09-27","relationship":"same-class"},{"drugName":"fremanezumab","drugSlug":"fremanezumab","fdaApproval":"2018-09-14","relationship":"same-class"},{"drugName":"ubrogepant","drugSlug":"ubrogepant","fdaApproval":"2019-12-23","patentExpiry":"Nov 10, 2031","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"rimegepant","drugSlug":"rimegepant","fdaApproval":"2020-02-27","patentExpiry":"Mar 25, 2039","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"atogepant","drugSlug":"atogepant","fdaApproval":"2021-09-28","patentExpiry":"Sep 27, 2042","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"eptinezumab","indications":{"approved":[{"name":"Migraine","source":"DrugCentral","snomedId":37796009,"regulator":"FDA","eligibility":"adults","usPrevalence":39000000,"globalPrevalence":1000000000,"prevalenceMethod":"curated","prevalenceSource":"Lancet Neurology, 2023"},{"name":"Prevention of migraine attacks","source":"DrugCentral","snomedId":408381007,"regulator":"FDA","usPrevalence":39000000,"globalPrevalence":1000000000,"prevalenceMethod":"curated","prevalenceSource":"Lancet Neurology, 2023"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"erenumab","brandName":"erenumab","genericName":"erenumab","approvalYear":"2018","relationship":"same-class"},{"drugId":"galcanezumab","brandName":"galcanezumab","genericName":"galcanezumab","approvalYear":"2018","relationship":"same-class"},{"drugId":"fremanezumab","brandName":"fremanezumab","genericName":"fremanezumab","approvalYear":"2018","relationship":"same-class"},{"drugId":"ubrogepant","brandName":"ubrogepant","genericName":"ubrogepant","approvalYear":"2019","relationship":"same-class"},{"drugId":"rimegepant","brandName":"rimegepant","genericName":"rimegepant","approvalYear":"2020","relationship":"same-class"},{"drugId":"atogepant","brandName":"atogepant","genericName":"atogepant","approvalYear":"2021","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT04965675","phase":"PHASE3","title":"A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine","status":"RECRUITING","sponsor":"H. Lundbeck A/S","startDate":"2021-06-30","conditions":["Chronic Migraine in Children"],"enrollment":285,"completionDate":"2026-10-31"},{"nctId":"NCT05897320","phase":"PHASE3","title":"A Study of Eptinezumab in Pediatric Participants With Episodic Migraine","status":"RECRUITING","sponsor":"H. Lundbeck A/S","startDate":"2023-06-08","conditions":["Episodic Migraine"],"enrollment":315,"completionDate":"2027-08-31"},{"nctId":"NCT05164172","phase":"PHASE3","title":"A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine","status":"RECRUITING","sponsor":"H. Lundbeck A/S","startDate":"2021-12-01","conditions":["Migraine"],"enrollment":600,"completionDate":"2028-04-30"},{"nctId":"NCT06701526","phase":"PHASE4","title":"A Trial of Eptinezumab in Participants With Migraine and Insufficient Response to Anti-CGRP Medications","status":"ACTIVE_NOT_RECRUITING","sponsor":"H. Lundbeck A/S","startDate":"2024-12-18","conditions":["Migraine"],"enrollment":150,"completionDate":"2026-06-05"},{"nctId":"NCT05452239","phase":"PHASE4","title":"A Study of Eptinezumab in Participants With Migraine and Medication Overuse Headache","status":"COMPLETED","sponsor":"H. 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