Posted by Michael Wonder on 14 Dec 2023
Apellis provides update on on-going regulatory review of pegcetacoplan for GA in the European Union
14 December 2023 - Apellis Pharmaceuticals announced today an update on the on-going review of its marketing authorisation application for intravitreal pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration by the CHMP of the EMA.
Following the oral explanation meeting on 13 December, Apellis was informed of a negative trend vote on the marketing authorisation application for pegcetacoplan. Apellis expects the CHMP to adopt a negative opinion at its next meeting, which is scheduled to be held 22-25 January 2024. If a negative opinion is adopted, Apellis plans to appeal the outcome and seek re-examination of the opinion.
