Apellis expects CHMP to adopt negative opinion on MAA for pegcetacoplan

Apellis Pharmaceuticals announced an update on the ongoing review of its marketing authorization application for intravitreal pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration by the Committee for Medicinal Products for Human Use of the European Medicines Agency. 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. 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.