Apellis Provides Update on Ongoing Regulatory Review of Pegcetacoplan for GA in the European Union

About this update from Apellis Pharmaceuticals, Inc.

[{"type":"text","content":"Conference call today at 8:30 a.m. ET\nWALTHAM, Mass., Dec. 14, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announced today an update on the ongoing review of its marketing authorization application (MAA) for intravitreal pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Following the oral explanation meeting on December 13, Apellis was informed of a negative trend vote on the MAA for pegcetacoplan. Apellis expects the CHMP to adopt a negative opinion at its next meeting, which is scheduled to be held January 22-25, 2024. If a negative opinion is adopted, Apellis plans to appeal the outcome and seek re-examination of the opinion. “We are very disappointed in this outcome and saddened for the millions of GA patients in Europe who have no treatment for this leading cause of blindness,” said Jeffrey Eisele, Ph.D., chief development officer, Apellis. “We firmly believe in the strength of the Phase 3 results, and we will continue working closely with the CHMP, the retina community, and patient advocacy groups with the goal of bringing pegcetacoplan to GA patients in Europe.” The MAA is based on results from the Phase 3 OAKS and DERBY studies at 24 months, which were published in The Lancet. Treatment with both every-other-month and monthly pegcetacoplan reduced GA lesion growth with increasing treatment effects over time and showed a well-demonstrated safety profile. Additionally, pegcetacoplan preserved visual function longer in multiple post hoc Phase 3 analyses that have been presented at medical congresses. More than 2.5 million people in Europe are living with GA,1 a progressive and irreversible form of vision loss that severely impairs independence and quality of life. Conference Call and WebcastApellis will host a conference call and webcast to discuss the CHMP trend vote on Thursday, December 14 at 8:30 a.m. ET. To access the live call by phone, please pre-register for the call here. A live audio webcast of the event may also be accessed through the “Events and Presentations” page of the “Investors and Media” section of the company’s website. A replay of the webcast will be available for 30 days following the event. About the Phase 3 OAKS an...

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