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# Apellis NDA for Geographic Atrophy Drug
- URL: https://www.fdaweb.com/apellis-nda-for-geographic-atrophy-drug/
- Published: 2022-07-19T12:00:00.000Z
- Updated: 2026-09-14T17:52:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152311

FDA has accepted for priority review an Apellis Pharmaceuticals NDA for intravitreal pegcetacoplan, an investigational, targeted C3 therapy for treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The agency set a user fee review action target date of 11/26.

GA is an advanced form of AMD and a leading cause of blindness that affects about one million people in the U.S., according to the company. GA is caused by the destruction of retinal cells through irreversible lesion growth, it says, adding that it takes about 2.5 years for GA lesions to affect the fovea, which is responsible for central vision.

The submission is based on results from the Phase 3 DERBY and OAKS studies at 12 and 18 months and the Phase 2 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,” Apellis says. “Pegcetacoplan demonstrated a favorable safety profile in all three studies.”