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Apellis Announces Pegcetacoplan MAA Review Has Been Reset to Day 180 of Initial Assessment by European Medicines Agency (EMA)
Decision by EMA follows recent judgment by the Court of Justice of the European Union regarding the organization of EMA’s expert groupsApellis anticipates a
About this update from Apellis Pharmaceuticals, Inc.
[{"type":"text","content":"Decision by EMA follows recent judgment by the Court of Justice of the European Union regarding the organization of EMA’s expert groupsApellis anticipates a CHMP opinion no later than July 2024 WALTHAM, Mass., April 26, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today 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. About ApellisApellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first-ever therapy for geographic atrophy, a leading cause of blindness around the world. We believe we have only begun to unlock the potential of targeting C3 across serious retinal, rare, and neurological diseases. For more information, please visit http://apellis.com or follow us on Twitter and LinkedIn. Apellis Forward-Looking StatementStatements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “pre...