Industry News
FDA Approves Apellis Pharmaceuticals’ Syfovre for Geographic Atrophy
Apellis Pharmaceuticals, a global biopharmaceutical company, has announced that its pegcetacoplan injection, Syfovre, has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). This marks a significant milestone as Syfovre is the first and only FDA-approved treatment for GA, which affects over 5 million people worldwide and is a leading cause of blindness.
According to Eleonora Lad, MD, PhD, lead investigator for the Oaks study and director of ophthalmology clinical research at Duke University Medical Center, "The approval of Syfovre is the most important event in retinal ophthalmology in more than a decade." Cedric Francois, MD, PhD, co-founder and CEO of Apellis, also stated that "GA is a complex disease that the field has spent decades trying to address, so we are humbled and proud to bring forward the first-ever treatment."
The approval of Syfovre is based on positive results from the Phase 3 Oaks and Derby studies at 24 months across a broad and representative population of patients. Syfovre is approved for GA patients with or without subfoveal involvement and provides dosing flexibility for patients and physicians with a dosing regimen of every 25 to 60 days.
Syfovre is expected to be available by the beginning of March through specialty distributors and specialty pharmacies nationwide in the US. A marketing authorization application for Syfovre is under review by the European Medicines Agency with a decision expected in early 2024, and a marketing application has been submitted to Health Canada. SYFOVRE is the first and only FDA-approved treatment for GA, with the therapy also being tested at trial sites in Australia. Jeff Todd, president and CEO of Prevent Blindness, called this a historic and hopeful day for GA patients and their care partners.
