Apellis Announces Pegcetacoplan MAA Review Has Been Reset to Day 180 of Initial Assessment by European Medicines Agency (EMA)

Core Viewpoint - The European Medicines Agency (EMA) has reset the review process for Apellis Pharmaceuticals' marketing authorization application for intravitreal pegcetacoplan, with an expected opinion from the Committee for Medicinal Products for Human Use (CHMP) by July 2024 [1][2]. Group 1: Regulatory Update - The EMA's decision follows a recent ruling by the Court of Justice of the European Union regarding the organization of EMA's expert groups, which affects how EMA manages competing interests among experts [2]. - The reset of the review process is procedural and does not pertain to the data package for pegcetacoplan [2]. Group 2: Company Overview - Apellis Pharmaceuticals is a global biopharmaceutical company focused on developing therapies for challenging diseases, having introduced the first new class of complement medicine in 15 years [3]. - The company has two approved medicines targeting C3, including the first therapy for geographic atrophy, a major cause of blindness globally [3].