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EVENITY (ROMOSOZUMAB-AQQG)
EVENITY (generic name: ROMOSOZUMAB-AQQG) is a drug developed by AMGEN INC. It is currently FDA-approved for Postmenopausal osteoporosis.
Evenity, also known as Romosozumab, is a monoclonal antibody that inhibits sclerostin, a protein involved in bone formation. It is being studied for various conditions, including fracture healing, osteoporosis, and glucocorticoids toxicity, among others.
At a glance
| Generic name | ROMOSOZUMAB-AQQG |
|---|---|
| Sponsor | AMGEN INC |
| Target | Sclerostin |
| Therapeutic area | Bone |
| Phase | FDA-approved |
Approved indications
- Postmenopausal osteoporosis
Boxed warnings
- WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND CARDIOVASCULAR DEATH EVENITY may increase the risk of myocardial infarction, stroke, and cardiovascular death [see Warnings and Precautions (5.1) ] . EVENITY should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY should be discontinued. WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND CARDIOVASCULAR DEATH See full prescribing information for complete boxed warning. EVENITY may increase the risk of myocardial infarction, stroke and cardiovascular death. ( 5.1 ) EVENITY should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. ( 5.1 ) If a patient experiences a myocardial infarction or stroke during therapy, EVENITY should be discontinued. ( 5.1 )
Common side effects
- Arthralgia
- Headache
Serious adverse events
- All-cause mortality
- Nonfatal serious adverse events
- Myocardial infarction
- Stroke
Key clinical trials
- Efficacy of Romosozumab and Denosumab Combined Treatment in Postmenopausal Osteoporosis Patients with Multiple Fragility Fractures (Phase 4)
- Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Adolescents and Young Adults With Functional Hypothalamic Amenorrhea (Phase 3)
- An Open-label, Randomized, Teriparatide-controlled Study to Evaluate the Effect of Treatment With Romosozumab in Postmenopausal Women With Osteoporosis Previously Treated With Bisphosphonate Therapy (Phase 3)
- A Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteopo (Phase 2)
- Romosozumab Versus Denosumab for Osteoporosis in Long-term Glucocorticoid Users: an Open Randomized Controlled Trial (Phase 4)
- Investigating the Efficacy of Romosozumab in Augmenting Bone Density and Muscle Mass to Enhance the Outcomes of Spine Surgery (Phase 2)
- A Pilot Study of Romosozumab Efficacy and Safety for the Management of Myelomarelated OsteoLytic Disease in Postmenopausal Women With Multiple Myeloma and Osteoporosis (REMOLD-MM) (Phase 1)
- Romosozumab Versus Denosumab in Patients With Glucocorticoid-induced Osteoporosis: a 2-year Extension Study of a Randomized Controlled Trial (Phase 4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- EVENITY CI brief — competitive landscape report
- EVENITY updates RSS · CI watch RSS
- AMGEN INC portfolio CI
Frequently asked questions about EVENITY
What is EVENITY?
EVENITY (ROMOSOZUMAB-AQQG) is a pharmaceutical drug developed by AMGEN INC, indicated for Postmenopausal osteoporosis.
What is EVENITY used for?
EVENITY is indicated for Postmenopausal osteoporosis.
Who makes EVENITY?
EVENITY is developed and marketed by AMGEN INC (see full AMGEN INC pipeline at /company/amgen).
What is the generic name of EVENITY?
ROMOSOZUMAB-AQQG is the generic (nonproprietary) name of EVENITY.
What development phase is EVENITY in?
EVENITY is FDA-approved (marketed).
What are the side effects of EVENITY?
Common side effects of EVENITY include Arthralgia, Headache. Serious adverse events: All-cause mortality, Nonfatal serious adverse events, Myocardial infarction, Stroke.
What does EVENITY target?
EVENITY targets Sclerostin.
Related
- Target: All drugs targeting Sclerostin
- Manufacturer: AMGEN INC — full pipeline
- Therapeutic area: All drugs in Bone
- Indication: Drugs for Postmenopausal osteoporosis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing