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Apellis: CHMP adopts negative opinion on MAA of intravitreal pegcetacoplan

Apellis Pharmaceuticals announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a negative opinion on the marketing authorization application of intravitreal pegcetacoplan for the treatment of geographic atrophy. Notably, there were multiple dissenting votes by CHMP members to this opinion. Apellis plans to seek re-examination and expects a final opinion in the fourth quarter of 2024. This opinion followed an Ad Hoc Expert Group meeting, in which the experts agreed that size of GA lesion is an acceptable primary outcome measure for a trial in GA and that microperimetry is the best available functional measure in GA.

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