The FDA approved a supplemental application for Empaveli (pegcetacoplan) on February 8, 2023. The FDA record classifies the action as an efficacy supplement under NDA 215014 and identifies APELLIS PHARMS as the sponsor.
The supplied record documents a regulatory action, not clinical-trial results. It does not provide a new indication, patient population, dosing change, efficacy measurements, safety findings, or comparative data. The approval therefore establishes that the FDA accepted the supplemental efficacy application, while the specific content of the supplement is not described in the supplied data.
Background
Pegcetacoplan is listed in the record under the brand names Empaveli and Syfovre. The supplied FDA entry does not provide drug-class, mechanism-of-action, disease-prevalence, or indication details. It identifies the application as an efficacy supplement rather than describing the clinical or labeling claims covered by the submission.
What this means
The February 2023 action confirms an FDA approval involving Empaveli’s supplemental efficacy application. Because the supplied record does not state what efficacy information was added or changed, it does not support conclusions about treatment benefit, a new approved use, patient eligibility, or safety. Clinicians, researchers, patient advocates, and editors seeking those details should review the underlying FDA application materials and current prescribing information.
The event is recorded as NDA 215014-SUPPL-2. The available summary lists the sponsor as APELLIS PHARMS and the supplement class as Efficacy. No trial identifier or outcome dataset was included with the event.
Source
Source: U.S. Food and Drug Administration, Drug Approval Details record for NDA 215014, supplemental application event dated February 8, 2023. The authoritative source is hosted at accessdata.fda.gov.