Apellis Pharmaceuticals, Inc. provided an update on its New Drug Application (NDA) for intravitreal pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The company plans to submit the 24-month efficacy data from the Phase 3 DERBY and OAKS studies as part of its application. As previously announced [1], these data showed robust and consistent effects with monthly and every-other-month pegcetacoplan treatment in both studies.

The 24-month safety data were previously submitted as part of the 120-day update. The submission is planned for November 2022 and will be a Major Amendment to the NDA, extending the review period by three months with an expected Prescription Drug User Fee Act (PDUFA) target action date in February 2023. 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.