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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

DateArticle
May 14, 2021Approval  FDA Approves Empaveli (pegcetacoplan) for Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH)
Nov 16, 2020Apellis Announces FDA Acceptance and Priority Review of the New Drug Application for Pegcetacoplan for the Treatment of PNH
Sep 15, 2020Apellis Announces Submission of Pegcetacoplan Marketing Applications to FDA and EMA for Patients with PNH
May 21, 2020Apellis Announces Plans to Submit NDA for Pegcetacoplan in Paroxysmal Nocturnal Hemoglobinuria (PNH)

Further information

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