Apellis submits NDA for pegcetacoplan for treatment of geographic atrophy
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Apellis Pharmaceuticals submitted a new drug application to the FDA for intravitreal pegcetacoplan, a targeted C3 therapy for the treatment of geographic atrophy secondary to age-related macular degeneration, according to a press release.
The submission is based on the results of the phase 3 DERBY and OAKS studies, as well as the phase 2 FILLY study. Pegcetacoplan demonstrated reduction in geographic atrophy (GA) lesion growth in more than 1,500 participants with treatment both monthly and every other month. The therapy also had a favorable safety profile in the studies.
“Pegcetacoplan is the only treatment that has shown the potential to meaningfully slow disease progression across three large studies with a representative, real-world population of GA patients,” Apellis chief development officer Jeffrey Eisele, PhD, said in the release. “With the submission of our marketing application in the United States, we are now one step closer towards our goal of bringing the first GA treatment to patients living with this relentless and irreversible disease.”
Apellis expects a decision on the NDA filing from the FDA in August and plans to submit a marketing authorization application to the European Medicines Agency later this year.
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