The FDA has granted fast track designation to Apellis Pharmaceuticals’ APL-2 as monotherapy for treatment of geographic atrophy, according to a company press release.
A fast track designation will expedite both the development and review of APL-2, a complement factor C3 inhibitor.
“The fast track designation represents an important recognition by the FDA of APL-2’s potential to treat geographic atrophy, a blinding disease for which there is no treatment,” Apellis founder and CEO Cedric Francois, MD, PhD, said. “The severe vision loss associated with GA makes it difficult for patients to recognize faces, read, drive a car and go about their daily lives, limiting quality of life. We believe that by slowing down the rate of degeneration through broad C3 inhibition, we may be able to improve outcomes for these patients.”
Phase 3 trials for the drug are expected to begin later this year, according to the release.