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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).

Development timeline for Empaveli

Oct  2, 2023Approval Apellis Announces U.S. FDA Approval of the Empaveli Injector, a Device to Streamline Self-Administration
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)
Feb 11, 2019Apellis Pharmaceuticals’ APL-2 Receives Fast Track Designation from the FDA for the Treatment of Patients with Paroxysmal Nocturnal Hemoglobinuria

Further information

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