CHMP Upholds Negative Opinion on Apellis' Pegcetacoplan for Geographic Atrophy

Apellis Pharmaceuticals faced another challenge as the EMA's Committee for Medicinal Products for Human Use (CHMP) upheld its negative opinion on pegcetacoplan, a treatment for geographic atrophy (GA). Despite strong support from the European retina community and dissenting votes from CHMP members, the treatment remains unapproved in Europe.

“We are deeply disappointed by this outcome, which leaves millions of Europeans with GA without a treatment for this irreversible form of blindness,” said Cedric Francois, CEO of Apellis. Despite this, Apellis is committed to expanding access in other regions. "We remain focused on unmet patient needs globally,” Francois added. Professor Frank G. Holz expressed concern, stating, “The phase 3 data for pegcetacoplan were clinically meaningful and demonstrated real potential for EU patients.”

Apellis remains committed to advancing pegcetacoplan in other regions, following its approval in the U.S. under the brand name Syfovre for GA patients in 2023.

Geographic Atrophy (GA)

Geographic Atrophy is an advanced form of age-related macular degeneration, leading to progressive and irreversible vision loss. Affecting millions, GA patients experience gradual deterioration in their ability to perform daily tasks such as reading, driving, and recognizing faces. Learn more about geographic atrophy and challenges patients face here: Geographic Atrophy & Patients With GA.