FDA Accepts New Data on Apellis’ New Drug Application
The FDA has accepted Apellis Pharmaceuticals’ major amendment to its new drug application (NDA) for pegcetacoplan for the treatment of patients with geographic atrophy secondary to age-related macular degeneration (AMD), a leading cause of blindness.
The amendment was the inclusion of 24-month efficacy data from two phase 3 studies. The company also plans on including the data in its marketing authorization application to the European Medicines Agency by the end of this year.
Pegcetacoplan is an investigational, targeted C3 therapy designed to regulate excessive activation of the complement system.
The FDA previously granted pegcetacoplan Fast Track designation for the treatment of geographic atrophy. The agency’s action date for this NDA is Feb. 26, 2023.
About 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.
November 22, 2022