Bkemv FDA Approval History
Last updated by Judith Stewart, BPharm on June 19, 2024.
FDA Approved: Yes (First approved May 28, 2024)
Brand name: Bkemv
Generic name: eculizumab-aeeb
Dosage form: Injection
Company: Amgen Inc.
Treatment for: Paroxysmal Nocturnal Hemoglobinuria, Hemolytic Uremic Syndrome
Bkemv (eculizumab-aeeb) is a complement inhibitor interchangeable biosimilar to Soliris for the treatment of paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
- Bkemv is indicated for:
- the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.
- the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.
Limitation of Use: Bkemv is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). - Bkemv is biosimilar to Soliris and has an interchangeability designation.
- Bkemv is administered by intravenous infusion over 35 minutes in adults and 1 to 4 hours in pediatric patients.
- FDA approval of Bkemv was based on a comprehensive review of scientific evidence that demonstrated the product was highly similar to Soliris, and that there were no clinically meaningful differences from Soliris.
- Bkemv comes with a Boxed Warning for serious meningococcal infections. Bkemv is available only through a restricted program called Bkemv REMS. Warnings and precautions associated with Bkemv include caution when administering Bkemv to patients with any other systemic infection, and infusion-related reactions.
- Common adverse reactions in PNH patients include headache, nasopharyngitis, back pain, and nausea.
Common adverse reactions in aHUS patients include headache, diarrhea, hypertension, upper respiratory infection, abdominal pain, vomiting, nasopharyngitis, anemia, cough, peripheral edema, nausea, urinary tract infections, and pyrexia.
Development timeline for Bkemv
Further information
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