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Apellis Reiterates Plans to Submit a New Drug Application in the First Half of 2022 for Pegcetacoplan for Geographic Atrophy Following FDA Feedback
WALTHAM, Mass., Nov. 12, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that it received formal, written feedback from
About this update from Apellis Pharmaceuticals, Inc.
[{"type":"text","content":"WALTHAM, Mass., Nov. 12, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that it received formal, written feedback from the U.S. Food and Drug Administration (FDA) that further reinforces the company’s plans to submit a New Drug Application (NDA) for intravitreal pegcetacoplan for geographic atrophy (GA) secondary to age-related macular degeneration. The NDA will be supported by efficacy and safety data from the Phase 3 DERBY and OAKS studies and the Phase 2 FILLY study. In the written feedback, the FDA stated that they do not make a distinction between Phases, provided a clinical trial is adequate and well controlled, and that all three studies appear to be adequate and well controlled. Based on this feedback, Apellis remains on track to submit an NDA in the first half of 2022 and believes that no additional studies will be needed for the NDA submission. “We are pleased that the FDA’s feedback is consistent with our plans to submit an NDA for pegcetacoplan in GA based on data from more than 1,500 patients across three randomized, well-controlled studies,” said Federico Grossi, M.D., Ph.D., chief medical officer, Apellis. “We look forward to working closely with the FDA to bring the first potential treatment to people living with GA, a devastating disease that leads to blindness.” About DERBY and OAKS DERBY (621 patients enrolled) and OAKS (637 patients enrolled) are Phase 3, multicenter, randomized, double-masked, sham-controlled studies evaluating the efficacy and safety of intravitreal pegcetacoplan in 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 0.05) at 12 months. Patients in DERBY and OAKS will continue to receive masked treatment for 24 months. About FILLYThe FILLY study was a 246-patient, Phase 2, multicenter, randomized, single-masked, sham-controlled study evaluating the efficacy and safety of intravitreal pegcetacoplan in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The primary objective of the study was to evaluate the efficacy of pegcetacoplan in patients with GA asse...