Apellis Announces Pegcetacoplan MAA Review Reset to Initial Assessment by European Medicines Agency
April 26, 2024 at 12:15 pm
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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.
Apellis Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company. The Company is focused on the discovery, development and commercialization of novel therapeutic compounds to treat diseases with high unmet needs through the inhibition of the complement system. SYFOVRE (pegcetacoplan injection) is the Companyâs approved treatment for geographic atrophy secondary to age-related macular degeneration (GA). Its EMPAVELI (pegcetacoplan), is for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). Its Aspaveli (pegcetacoplan) for the treatment of adults with PNH who are anemic after treatment with a C5 inhibitor for at least three months. Systemic pegcetacoplan has also been approved for the treatment of PNH in Japan, Saudi Arabia, Australia, the United Kingdom and other jurisdictions. Systemic pegcetacoplan is marketed under the trade name EMPAVELI in the United States, Saudi Arabia and Australia and Aspaveli in the European Union, Japan and United Kingdom.