FDA grants priority review to pegcetacoplan for geographic atrophy treatment
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The FDA accepted a new drug application for intravitreal pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration and granted priority review designation, according to a press release.
The NDA submission was based on results from the phase 2 FILLY study at 12 months and the phase 3 DERBY and OAKS studies at 12 months and 18 months, according to Apellis Pharmaceuticals. The studies resulted in a clinically meaningful reduction of geographic atrophy (GA) lesion growth in more than 1,500 patients following intravitreal pegcetacoplan dosed monthly or every other month, with a favorable safety profile.
The FDA set the Prescription Drug User Fee Act target action date as Nov. 26, with no advisory committee meetings currently planned.
“This important milestone marks our second NDA acceptance in less than 2 years, a testament to the potential of targeting C3 to treat serious diseases with significant unmet need,” Jeffrey Eisele, PhD, chief development officer at Apellis, said in the release. “We are committed to working closely with the FDA to bring this potential first-ever treatment to patients living with GA as quickly as possible.”
In addition, the company plans to submit a marketing authorization application to the European Medicines Agency later this year, according to the release.
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