The FDA approved Empaveli (pegcetacoplan) on May 14, 2021, in an initial approval action under NDA 215014. The application sponsor was Apellis Pharmaceuticals, and the FDA classified the product as a Type 1 new molecular entity.
Background
Pegcetacoplan is listed in the supplied FDA record under the brand name Empaveli. The same drug data also identify the aliases pegcetacoplan and Syfovre. The supplied record classifies Empaveli as a Type 1 new molecular entity, but does not provide mechanism details, a therapeutic indication, dosing information, or condition-specific clinical findings.
What this means
The May 14, 2021 action records an initial FDA approval for Empaveli under NDA 215014. Because the supplied event data do not state the approved indication or patient population, this report does not assign a disease use or describe the approval beyond the information documented in the FDA record. The record also does not include trial outcomes, comparative results, safety findings, or dosing instructions.
For clinicians, researchers, patient advocates, and editors, the key verification points are the product name, the approval date, the application number, the sponsor, and the FDA classification. Any assessment of the approved use should be checked against the FDA labeling and application materials associated with NDA 215014.
Source
Source: FDA, Drug Approval Database overview record for NDA 215014, reflecting the initial approval dated May 14, 2021. The authoritative record is hosted at accessdata.fda.gov.