Apellis: EU's CHMP Adopts Negative Opinion For Pegcetacoplan For GA; To Seek Re-Examination Of MAA

(RTTNews) - Apellis Pharmaceuticals, Inc. (APLS) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP has adopted a negative opinion for Pegcetacoplan for geographic atrophy or GA. The company said it plans to seek immediate re-examination of its marketing authorization application or MAA.

The negative opinion was given on the MAA of intravitreal pegcetacoplan for the treatment of GA secondary to age-related macular degeneration or AMD.

As announced earlier, the opinion was expected based on a negative trend vote following an oral explanation meeting in December 2023.

The MAA is based on results from the Phase 3 OAKS and DERBY studies at 24 months, which were published in The Lancet.

The company noted that treatment with both every-other-month and monthly pegcetacoplan reduced GA lesion growth with increasing treatment effects over time and showed a well-demonstrated safety profile.

Additionally, pegcetacoplan preserved visual function longer in multiple post hoc Phase 3 analyses that have been presented at medical congresses.

Jeffrey Eisele, chief development officer, Apellis, said, "We are very disappointed in this outcome on behalf of the millions of Europeans with GA who currently have no treatment options for this irreversible form of blindness. We plan to promptly initiate the re-examination of our application and address CHMP questions, with the goal of bringing this first-ever potential treatment to the GA community in Europe."

In pre-market activity on Nasdaq, the shares were trading at $65.37, down 1.33 percent.

For More Such Health News, visit rttnews.com