Apellis submits MAA to EMA for pegcetacoplan for geographic atrophy

Apellis Pharmaceuticals announced that the company has submitted a Marketing Authorization Application to the European Medicines Agency for intravitreal pegcetacoplan, an investigational, targeted C3 therapy, for the treatment of geographic atrophy secondary to age-related macular degeneration. GA is a leading cause of blindness that impacts more than five million people globally. The MAA submission is based on results from the Phase 3 DERBY and OAKS studies at 24 months. In the studies, treatment with both every-other-month and monthly pegcetacoplan demonstrated robust and clinically meaningful reductions of GA lesion growth, with treatment effects that increased over time, and a favorable safety profile. The U.S. marketing application is under review with a Prescription Drug User Fee Act target action date of February 26, 2023.