Apellis to submit NDA for intravitreal pegcetacoplan to FDA in H1 2022
Apellis Pharmaceuticals said that it is on track to submit a new drug application (NDA) for its intravitreal pegcetacoplan to the US Food and Drug Administration (FDA) in the first half of 2022.
The US-based biopharma company said that np further studies are required for the submission of the NDA for seeking approval for the targeted C3 therapy — pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration.
Apellis Pharmaceuticals revealed that it has been issued formal feedback in writing from the FDA, which is said to further reinforce its plan to submit the NDA.
The company said that the NDA will be backed by data pertaining to the efficacy and safety of pegcetacoplan from phase 3 DERBY and OAKS clinical studies and the phase 2 FILLY clinical trial.
The FDA feedback stated that it does not make a distinction between phases if a clinical trial is found to be adequate and well controlled. The regulator wrote that all the three studies seem to be adequate and well controlled, said Apellis Pharmaceuticals.
Federico Grossi — chief medical officer of Apellis Pharmaceuticals said: “We are pleased that the FDA’s feedback is consistent with our plans to submit an NDA for pegcetacoplan in GA based on data from more than 1,500 patients across three randomized, well-controlled studies.
“We look forward to working closely with the FDA to bring the first potential treatment to people living with GA, a devastating disease that leads to blindness.”