The FDA approved a supplemental application for Empaveli (pegcetacoplan) on August 20, 2026. The action was classified as an efficacy matter under supplemental application NDA 215014 S-12.
The approval concerned Empaveli, also known as pegcetacoplan. The FDA record identified APELLIS PHARMS as the sponsor and described the submission as an efficacy application.
Background
Pegcetacoplan is listed in the supplied record under the brand names Empaveli and Syfovre. The data identify the drug’s class for this submission as Efficacy. The supplied information does not specify a new indication, patient population, dosing regimen, mechanism, or clinical outcome measurement associated with the supplemental approval.
What this means
The FDA action confirms approval of the supplemental efficacy application for Empaveli under NDA 215014. Because the supplied record does not describe the approved efficacy finding or provide supporting trial measurements, it does not establish a particular magnitude of benefit, comparative result, safety conclusion, or label change beyond the supplemental approval reported here.
Source
Source: U.S. Food and Drug Administration, FDA application overview record for supplemental application NDA 215014 S-12, dated August 20, 2026. The record is available through the FDA’s accessdata.fda.gov website.