The FDA has approved Apellis' substantial unsolicited change to the new drug application (NDA) for intravitreal pegcetacoplan to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD), according to an announcement from Apellis Pharmaceuticals.
The new Prescription Drug User Fee Act (PDUFA) target date is February 26, 2023. The FDA reiterated that they do not intend to arrange a meeting of the advisory committee to discuss the application.
“With the inclusion of the 24-month data, we have the potential to have the best product profile at launch for pegcetacoplan, with minimal impact to launch timing,” said Cedric Francois, MD, PhD, chief executive officer and co-founder, Apellis. “We appreciate the opportunity for the FDA to review these data and look forward to working with the agency to bring this first potential therapy to people living with GA as quickly as possible.”
The phase 3 DERBY and OAKS studies' 24-month effectiveness data will be submitted as part of the NDA assessment, Apellis stated earlier this month. The 24-month data revealed excellent safety profiles in both groups as well as rising and consistent effects with monthly and every-other-month pegcetacoplan treatment.
By the end of 2022, Apellis will submit an EU marketing authorization application to the European Medicines Agency, which will include the 24-month data.
About Pegcetacoplan for Geographic Atrophy (GA)
Pegcetacoplan is a targeted C3 therapy that is still under study and is intended to control the body's immune system's excessive complement cascade activation, which can cause the onset and development of many serious diseases. The FDA granted Pegcetacoplan Fast Track status for the treatment of geographic atrophy.