Fri Sep 20 09:12:04 UTC 2024: ## Apellis Pharmaceuticals’ Pegcetacoplan for Geographic Atrophy Denied European Approval

**WALTHAM, Mass., Sept. 20, 2024** – Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announced today that the European Medicines Agency (EMA) has rejected the marketing authorization application for intravitreal pegcetacoplan, a treatment for geographic atrophy (GA) secondary to age-related macular degeneration.

The Committee for Medicinal Products for Human Use (CHMP) of the EMA confirmed its June 2024 negative opinion on the application, despite widespread support from the European retina community and dissenting votes from CHMP members who favored approval.

“We are deeply disappointed by this outcome, which leaves millions of Europeans with GA without a treatment for this irreversible form of blindness,” stated Dr. Cedric Francois, CEO and co-founder of Apellis.

The company will continue to focus on expanding access to pegcetacoplan in the United States and other regions globally. Pegcetacoplan, marketed as SYFOVRE® in the US, has shown positive impact for GA patients in the country.

“It is disappointing to know that we will not be able to provide access to this treatment to GA patients in the EU,” said Professor Frank G. Holz, a prominent ophthalmologist and investigator on the OAKS and DERBY studies. “The Phase 3 data for pegcetacoplan are clinically meaningful and showed the potential to make a difference for EU patients.”

GA is a serious eye disease that affects over one million Americans and five million people worldwide. It is a leading cause of blindness and characterized by the growth of lesions that destroy retinal cells responsible for vision. This progressive and irreversible disease significantly impacts quality of life and independence, making it difficult for patients to perform everyday activities.

Pegcetacoplan is an investigational therapy designed to regulate the complement cascade, a part of the body’s immune system implicated in GA progression.

Apellis remains committed to developing life-changing therapies for patients battling serious diseases and is hopeful for future opportunities to provide access to pegcetacoplan in Europe.

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