Apellis Pharmaceuticals, Inc. is looking at a three-month extension of the US Food and Drug Administration action date for its pegcetacoplan in geographic atrophy (GA), but that’s because it is choosing to submit additional data to the agency. The firm opted for the short delay in order to have a more compelling dataset to take to the market.
Apellis said 3 November that it would submit 24-month Phase III data from the 637-patient DERBY and 621-patient OAKS clinical trials to the FDA, a move that the agency considered a major amendment to the new drug application (NDA) and that will push the Prescription Drug User Fee Act deadline from 26 November to February 2023
