The EMA decision against Syfovre’s approval

On September 19, 2024, The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) confirmed its refusal to provide marketing authorization for Syfovre (pegcetacoplan), the Apellis injectable drug for the treatment of geographic atrophy. This decision was taken after Apellis asked the EMA to re-examine the first negative opinion, issued on June 27, 2024.

The Agency motivated this decision with the lack of “clinically meaningful benefits for the patients”, with a proven “impact on patients’ everyday functioning”.  They also considered the adverse events related to pegcetacoplan injection, that include the development of neovascular AMD and inflammatory reactions that might affect vision, and concluded that “the magnitude of Syfovre’s effectiveness did not outweigh the potential risks.”

While Syfovre has been available since February 2023, GA patients in Europe remain without a treatment.

In this “Experts Arena”, retina specialists express their opinions, and look into the foreseen consequences of this decision.

Francesco Bandello, MD, FEBO

Department of Ophthalmology, Vita-Salute University, San Raffaele Hospital, Milan, Italy.

Italy

Marc D. de Smet, MDCM, PhD, FRCSC, FRCOphth, DABO, FMH

Professor and Head of MIOS, Lausanne, Switzerland. CMO of Preceyes

Switzerland

Jean-François Korobelnik, MD, PhD

Professor of Ophthalmology at the University Hospital of Bordeaux, France

France

Baruch D. Kuppermann, MD, PhD

Roger F. Steinert Professor, Chair of the Department of Ophthalmology, and Director of the Gavin Herbert Eye Institute at the University of California, Irvine.

USA

Paolo Lanzetta, MD

Professor and Chair of the Department of Ophthalmology, University of Udine and Scientific Director of the European Institute of Ocular Microsurgery (IEMO), Udine, Italy

Italy

Patricia Udaondo, MD, PhD

Associate Professor, University of Valencia and co-medical director of the Aiken clinic

Spain