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Apellis Announces FDA Acceptance of NDA Amendment and New PDUFA Date of February 26, 2023 for Pegcetacoplan for Geographic Atrophy (GA)
WALTHAM, Mass., Nov. 18, 2022 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement,
About this update from Apellis Pharmaceuticals, Inc.
[{"type":"text","content":"WALTHAM, Mass., Nov. 18, 2022 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the U.S. Food and Drug Administration (FDA) has accepted Apellis’ unsolicited major amendment to the New Drug Application (NDA) for intravitreal pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The updated Prescription Drug User Fee Act (PDUFA) goal date is February 26, 2023. The FDA also restated that they do not plan to hold an advisory committee meeting to discuss the application. “With the inclusion of the 24-month data, we have the potential to have the best product profile at launch for pegcetacoplan, with minimal impact to launch timing,” said Cedric Francois, M.D., Ph.D., chief executive officer and co-founder, Apellis. “We appreciate the opportunity for the FDA to review these data and look forward to working with the agency to bring this first potential therapy to people living with GA as quickly as possible.” Apellis announced earlier this month the company’s decision to submit 24-month efficacy data from the Phase 3 DERBY and OAKS studies as part of the NDA review. The 24-month data showed increasing and consistent effects with every-other-month and monthly pegcetacoplan treatment and a favorable safety profile in both studies. Apellis remains on track to submit an EU marketing authorization application, which will also include the 24-month results, to the European Medicines Agency by the end of 2022. About DERBY and OAKS DERBY (n=621) and OAKS (n=637) are Phase 3, multicenter, randomized, double-masked, sham-controlled studies comparing the efficacy and safety of pegcetacoplan with sham injections across a broad and representative population of patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The primary objective of the studies is to evaluate the efficacy of pegcetacoplan in patients with GA assessed by change in the total area of GA lesions from baseline as measured by fundus autofluorescence (p-value less than .05) at 12 months. Patients continued to receive masked treatment for 24 months. About Geographic Atrophy (GA)Geographic atrophy (GA) is an advanced form of age-related macular degeneration (AMD) and a leading cause of blindness ...