FDA accepts New Drug Application for pegcetacoplan for the treatment of geographic atrophy

The U.S. Food and Drug Administration has accepted and granted Priority Review designation for the intravitreal pegcetacoplan New Drug Application (NDA), according to a press release by Apellis Pharmaceuticals.

Pegcetacoplan is an investigational, targeted C3 therapy for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The Prescription Drug User Fee Act (PDUFA) target action date is November 26, 2022. The FDA has stated that it is not currently planning to hold an advisory committee meeting to discuss the application.

“This is a very exciting time for the retina community as we are closer than ever to having the first treatment for GA, an irreversible and devastating disease that causes a tremendous amount of vision loss,” said Charles Wykoff, MD, PhD, OAKS study investigator and director of research, Retina Consultants of Texas. “Both monthly and every-other-month pegcetacoplan meaningfully slowed GA disease progression across three large studies, and the potential approval of this medicine would be a breakthrough for patients.”

Read the full press release here.