FDA accepts and grants priority review of the NDA for pegcetacoplan for the treatment of geographic atrophy secondary to AMD.
Apellis Pharmaceuticals, Inc. announced that the FDA has accepted and granted Priority Review designation for the intravitreal pegcetacoplan New Drug Application (NDA).
Pegcetacoplan is an investigational, targeted C3 therapy for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The Prescription Drug User Fee Act (PDUFA) target action date is November 26, 2022. The FDA has stated that it is not currently planning to hold an advisory committee meeting to discuss the application.
The NDA submission is based on results from the Phase III DERBY and OAKS studies at 12 and 18 months and the Phase II FILLY study at 12 months. In the studies, treatment with both monthly and every-other-month pegcetacoplan resulted in a clinically meaningful reduction of GA lesion growth across a broad, heterogeneous population of more than 1,500 patients. Pegcetacoplan demonstrated a favorable safety profile in all three studies.
Priority Review designation is granted to marketing applications for medicines that treat a serious condition and if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition. Pegcetacoplan was previously granted Fast Track designation by the FDA for the treatment of GA secondary to AMD.
Apellis plans to submit a marketing authorization application to the European Medicines Agency in the second half of 2022.
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