Apellis announces pegcetacoplan MAA review has been reset to Day 180

Apellis Pharmaceuticals announced that the European Medicines Agency has reset the review of the marketing authorization application for intravitreal pegcetacoplan for geographic atrophy to the last phase of the initial assessment. 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 no later than July 2024. The update follows the judgment by the Court of Justice of the European Union 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.