Apellis’ APL-2 Receives FDA Fast Track Designation for GA

July 27, 2018: By Jon Swedien

Apellis Pharmaceuticals’ APL-2 has received the US FDA’s fast track designation for geographic atrophy (GA), the Louisville, Kentucky-based company announced July 24.

APL-2 is a novel inhibitor of complement factor C3 being developed as a monotherapy.

The fast track designation makes Apellis eligible for more frequent meetings and written communication with the FDA to discuss development plans and clinical trial design. The fast track program expedites the review of drugs to treat serious conditions and fill an unmet medical need.

Apellis plans to initiate a Phase III trial later in 2018. It will consist of two identical, prospective, multicenter, randomized, double-masked, sham-injection controlled studies assessing the efficacy and safety of multiple intravitreal injections of APL-2 in patients with GA.

Also, if Apellis meets certain criteria, the FDA will allow the company to submit completed sections of its new drug application before the entire application is finished to speed the review process.

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