Empaveli FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 4, 2023.
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).
- PNH is a rare, chronic, life-threatening blood disorder characterized by the destruction of oxygen-carrying red blood cells through extravascular and intravascular hemolysis. Low hemoglobin levels can result in frequent transfusions and debilitating symptoms such as severe fatigue, hemoglobinuria, and dyspnea.
- Empaveli is a targeted C3 therapy that works in the treatment of PNH by binding to complement protein C3 and its activation fragment C3b to regulate excessive activation of the complement cascade, which stops extravascular and intravascular hemolysis.
- Empaveli is administered subcutaneously twice weekly by subcutaneous infusion via a commercially available infusion pump or with the Empaveli Injector.
- 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
Further information
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