The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review designation for Apellis Pharmaceuticals’ APLS New Drug Application (NDA) for the intravitreal pegcetacoplan.
The regulatory agency has assigned target action date of November 26, 2022.
The New Drug Application is supported by the data readout from the Phase 3 DERBY and OAKS studies at 12 and 18 months and the Phase 2 FILLY study at 12 months. The lead drug, Pegcetacoplan demonstrated a favorable safety profile in all three studies.
Jeffrey Eisele, Chief development officer, said, This important milestone marks our second NDA acceptance in less than two years, a testament to the potential of targeting C3 to treat serious diseases with significant unmet need, We are committed to working closely with the FDA to bring this potential, first-ever treatment to patients living with GA as quickly as possible.”
Pegcetacoplan was previously granted Fast Track designation by the agency for the treatment of GA secondary to AMD.
The FDA grants Priority Review that shortens review of NDA, applicable for medicines that may offer significant improvements in the treatment, diagnosis, or prevention of a serious condition.
Additionally, the company plans to submit a marketing authorization application to the European Medicines Agency in the second half of 2022.
Price Action : Apellis shares are trading around 23 percent higher at $55.20 on Tuesday during pre-market session.