FDA Approves First Treatment for Geographic Atrophy, Accepts NDA for Same Indication
The FDA has approved Apellis Pharmaceuticals’ Syfovre (pegcetacoplan) injection as the first approved therapy to treat geographic atrophy secondary to age-related macular degeneration, a leading cause of blindness.
The approval was based on results from two phase 3 studies, with Syfovre showing reductions in the growth rate of geographic atrophy lesions and increasing treatment effects over time.
The FDA has also granted a priority review to another potential treatment for the same condition, Iveric Bio’s avacincaptad pegol, which the agency previously designated as a Breakthrough Therapy.
Iveric Bio’s new drug application (NDA) is supported by efficacy rates of up to 35 percent in two phase 3 trials. The FDA’s target decision date for the NDA is Aug. 19.
Apellis Pharmaceuticals Inc.
Apellis Pharmaceuticals Inc., is a clinical-stage biopharmaceutical company that focuses on the discovery and development of therapeutic compounds for autoimmune and inflammatory diseases through inhibition of the complement system at the level of C3 (central protein). Its pipeline product portfolio includes APL-2, a C3 inhibitor administered by intravitreal injections and subcutaneous injections for the treatment of geographic atrophy (GA), paroxysmal nocturnal hemoglobinuria (PNH), wet age-related macular degeneration (AMD), autoimmune hemolytic anemia (AIHA) and complement-dependent nephropathies. Apellis complement system activates C3 protein which enables immune responses such as opsonization, inflammation and formation of the membrane attack complex. It also conducts research on chronic therapy with a C3 inhibitor into clinical trials. The company operates with offices in the US, Ireland, Switzerland and Australia. Apellis is headquartered in Waltham, Massachusetts, the US.
February 23, 2023
