EMA’s CHMP Issues Negative Opinion of Syfovre for Geographic Atrophy

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the marketing authorization application (MAA) of Apellis’s intravitreal pegcetacoplan (Syfovre) for the treatment of geographic atrophy (GA). Apellis to seek re-examination.

European Medicines Agency in Amsterdam. Foto: Robert Meerding. © European Union, 2020
European Medicines Agency in Amsterdam. Foto: Robert Meerding. © European Union, 2020

This is the committee's reasoning: "Although the studies showed that Syfovre slowed the growth of geographic atrophy lesions, this did not lead to clinically meaningful benefits for patients. It was noted that benefits of a treatment should impact patients’ everyday functioning, and this was not demonstrated in the studies. In terms of safety, regular injections into the eye carry a significant risk of adverse events, including the development of other forms of AMD or inflammation in the eye, that could further worsen vision. Therefore, the Agency’s opinion was that a positive balance of benefits and risks of Syfovre in the treatment of geographic atrophy caused by AMD could not be established and it recommended refusing marketing authorisation."

Apellis stated in a press release, that there were multiple dissenting votes by CHMP members to this opinion. The company plans to seek re-examination and expects a final opinion in the fourth quarter of 2024. The committee's opinion followed an Ad Hoc Expert Group meeting, in which the experts agreed that size of GA lesion is an acceptable primary outcome measure for a trial in GA and that microperimetry is the best available functional measure in GA.

“We remain steadfast in our commitment to GA patients in Europe who have no treatment for this devastating disease, which leads to irreversible vision loss,” said Jeffrey Eisele, Ph.D., chief development officer, Apellis. “It is encouraging to see the broad support for pegcetacoplan within the European retina community, and we are focused on promptly initiating the re-examination to bring this important treatment to those in need.”

Sources: EMA / Apellis