Intravitreal pegcetacoplan filed with EU for geographic atrophy
Apellis Pharmaceuticals announced that the company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency for intravitreal pegcetacoplan, an investigational, targeted C3 therapy, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD)
The MAA submission is based on results from the Phase III 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 (PDUFA) target action date of February 26, 2023.
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