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BKEMV (ECULIZUMAB-AEEB)
BKEMV (generic name: ECULIZUMAB-AEEB) is a Complement Inhibitor [EPC] drug developed by AMGEN INC. It is currently FDA-approved for Paroxysmal Nocturnal Hemoglobinuria (PNH), Atypical Hemolytic Uremic Syndrome (aHUS), Generalized Myasthenia Gravis (gMG).
At a glance
| Generic name | ECULIZUMAB-AEEB |
|---|---|
| Sponsor | AMGEN INC |
| Drug class | Complement Inhibitor [EPC] |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
- Paroxysmal Nocturnal Hemoglobinuria (PNH)
- Atypical Hemolytic Uremic Syndrome (aHUS)
- Generalized Myasthenia Gravis (gMG)
Boxed warnings
- WARNING: SERIOUS MENINGOCOCCAL INFECTIONS Eculizumab products, complement inhibitors, increase the risk of serious infections caused by Neisseria meningitidis [see Warnings and Precautions (5.1) ] . Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early. Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of BKEMV, unless the risks of delaying therapy with BKEMV outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against meningococcal bacteria in patients receiving a complement inhibitor. See Warnings and Precautions (5.1) for additional guidance on the management of the risk of serious infections caused by meningococcal bacteria. Patients receiving eculizumab products are at increased risk for invasive disease caused by Neisseria meningitidis , even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious meningococcal infections and evaluate immediately if infection is suspected. Because of the risk of serious meningococcal infections, BKEMV is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called BKEMV REMS [ see Warnings and Precautions (5.2) ]. WARNING: SERIOUS MENINGOCOCCAL INFECTIONS See full prescribing information for complete boxed warning Eculizumab products increase the risk of serious and life-threatening infections caused by Neisseria meningitidis . Complete or update meningococcal vaccination at least 2 weeks prior to the first dose of BKEMV, unless the risks of delaying BKEMV outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients receiving a complement inhibitor. ( 5.1 ) Patients receiving eculizumab products are at increased risk for invasive disease caused by Neisseria meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of meningococcal infections and evaluate immediately if infection is suspected. ( 5.1 ) BKEMV is available only through a restricted program called BKEMV REMS. ( 5.2 )
Common side effects
- Headache
- Diarrhea
- Hypertension
- Upper respiratory infection
- Abdominal pain
- Vomiting
- Nasopharyngitis
- Anemia
- Cough
- Peripheral edema
- Nausea
- Urinary tract infections
Serious adverse events
- Meningococcal sepsis
- Meningococcal meningitis
- Viral infection
- Thrombotic event
- Progression of PNH
- Infections
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- BKEMV CI brief — competitive landscape report
- BKEMV updates RSS · CI watch RSS
- AMGEN INC portfolio CI
Frequently asked questions about BKEMV
What is BKEMV?
BKEMV (ECULIZUMAB-AEEB) is a Complement Inhibitor [EPC] drug developed by AMGEN INC, indicated for Paroxysmal Nocturnal Hemoglobinuria (PNH), Atypical Hemolytic Uremic Syndrome (aHUS), Generalized Myasthenia Gravis (gMG).
What is BKEMV used for?
BKEMV is indicated for Paroxysmal Nocturnal Hemoglobinuria (PNH), Atypical Hemolytic Uremic Syndrome (aHUS), Generalized Myasthenia Gravis (gMG).
Who makes BKEMV?
BKEMV is developed and marketed by AMGEN INC (see full AMGEN INC pipeline at /company/amgen).
What is the generic name of BKEMV?
ECULIZUMAB-AEEB is the generic (nonproprietary) name of BKEMV.
What drug class is BKEMV in?
BKEMV belongs to the Complement Inhibitor [EPC] class. See all Complement Inhibitor [EPC] drugs at /class/complement-inhibitor-epc.
What development phase is BKEMV in?
BKEMV is FDA-approved (marketed).
What are the side effects of BKEMV?
Common side effects of BKEMV include Headache, Diarrhea, Hypertension, Upper respiratory infection, Abdominal pain, Vomiting. Serious adverse events: Meningococcal sepsis, Meningococcal meningitis, Viral infection, Thrombotic event.
Related
- Drug class: All Complement Inhibitor [EPC] drugs
- Manufacturer: AMGEN INC — full pipeline
- Therapeutic area: All drugs in Other
- Indication: Drugs for Paroxysmal Nocturnal Hemoglobinuria (PNH)
- Indication: Drugs for Atypical Hemolytic Uremic Syndrome (aHUS)
- Indication: Drugs for Generalized Myasthenia Gravis (gMG)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing