Apellis Pharmaceuticals, Inc. announced that the European Medicines Agency (EMA) has reset the review of the marketing authorization application (MAA) for intravitreal pegcetacoplan for geographic atrophy to the last phase of the initial assessment (day 180). The procedure is expected to be led by the original rapporteurs, and EMA has stated their intent to convene a new expert group meeting. Apellis anticipates an opinion from the Committee for Medicinal Products for Human Use (CHMP) no later than July 2024. The update follows the judgment by the Court of Justice of the European Union (CJEU) on March 14, 2024, which ruled on the organization of EMA?s expert groups. The judgment has implications on EMA's policy for
handling competing interests of experts. This decision by EMA is strictly procedural in response to the CJEU judgment and is not related to the
pegcetacoplan data package. Apellis will continue to work closely with EMA on the review of the pegcetacoplan marketing application.