Apellis Pharmaceuticals, Inc. (APLS) has reported that its drug, Pegcetacoplan, for the treatment geographic atrophy (GA), has been rejected by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). Despite this setback, the company intends to request a swift re-examination of its marketing authorization application (MAA).
The refusal to grant the MAA came for intravitreal pegcetacoplan, which is intended to treat GA resulting from age-related macular degeneration (AMD).
As we have previously reported, this decision was anticipated due to a negative trend vote that followed a verbal explanation meeting in December 2023.
The MAA was primarily based on the results from the Phase 3 OAKS and DERBY studies, over a duration of 24 months, the details of which have been published in The Lancet.
According to Apellis, treatment with both monthly and bimonthly pegcetacoplan demonstrated reduction in GA lesion growth over time, and the safety profile of the drug was sufficiently substantiated.
The drug also extended the preservation of visual function in several post hoc Phase 3 analyses results that were presented at medical conferences.
Jeffrey Eisele, the Chief Development Officer at Apellis, expressed his deep disappointment on behalf of the millions of Europeans living with GA who lack any current treatment options for this form of irreversible blindness. He announced the company's intention to kickstart the re-examination of the MAA with the aim to address CHMP's questions and facilitate the introduction of this potential treatment for GA patients in Europe.
In pre-market trading on Nasdaq, the company's shares were down 1.33 percent, trading at $65.37.
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