Empaveli FDA Approval History
Last updated by Judith Stewart, BPharm on May 19, 2021.
FDA Approved: Yes (First approved May 14, 2021)
Brand name: Empaveli
Generic name: pegcetacoplan
Dosage form: Injection
Company: Apellis Pharmaceuticals, Inc.
Treatment for: Paroxysmal Nocturnal Hemoglobinuria
Empaveli (pegcetacoplan) is a targeted C3 inhibitor for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).
- Empaveli is administered twice weekly by subcutaneous infusion via a commercially available infusion pump.
- The Empaveli product label carries a boxed warning for the increased risk of meningococcal and other serious infections caused by encapsulated bacteria. Because of this risk, Empaveli is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS).
- Common adverse reactions include injection-site reactions, infections, diarrhea, abdominal pain, respiratory tract infection, viral infection, and fatigue.
Development timeline for Empaveli
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