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.