Benzinga | Nov 12, 2021 07:12AM EST

Apellis Pharma Reiterates Plan To Submit New Drug Application In H1'22 For Pegcetacoplan For Geographic Atrophy Following FDA Feedback

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."