Pegcetacoplan for geographic atrophy receives negative opinion from European committee
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Key takeaways:
- The opinion was expected after a negative trend vote in December.
- Apellis will seek reexamination of the application.
The Committee for Medicinal Products for Human Use of the European Medicines Agency issued a negative opinion on a marketing authorization application for pegcetacoplan, according to an Apellis Pharmaceuticals press release.
The opinion was expected based on a negative trend vote after an oral explanation meeting in December 2023, the release said.
The application for intravitreal pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration was based on the phase 3 OAKS and DERBY studies, which compared the efficacy and safety of pegcetacoplan with sham injection. At 24 months, the studies showed every-other-month and monthly treatments with pegcetacoplan reduced GA lesion growth with increasing effects over time. Additional post hoc phase 3 analyses showed pegcetacoplan preserved vision even longer, according to the release.
Since the FDA approval of pegcetacoplan in February 2023, there have been 14 confirmed cases of retinal vasculitis that occurred after the first injection of the targeted C3 therapy. The incidence of retinal vasculitis is not yet known.
“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,” Jeffrey Eisele, PhD, Apellis chief development officer, said in the release. “We plan to promptly initiate the reexamination of our application and address CHMP questions, with the goal of bringing this first-ever potential treatment to the GA community in Europe.”
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