EMA’s CHMP Issues Negative Opinion of Syfovre for GA; Apellis to Seek Re-Examination

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 for the treatment of geographic atrophy (GA).

“Although the studies showed that Syfovre slowed the growth of geographic atrophy lesions, this did not lead to clinically meaningful benefits for patients,” the CHMP posted on EMA’s website[1]. “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.”

In a news release, Apellis pointed out that there were multiple dissenting votes by CHMP members to this opinion. Apellis said it plans to seek re-examination and expects a final opinion in the fourth quarter of 2024.

“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, PhD, 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.”

The FDA approved Syfovre (pegcetacoplan) in February 2023 as the first FDA approved treatment for GA. 

References

1.  European Medicines Agency. Syfovre Overview. https://www.ema.europa.eu/en/medicines/human/EPAR/syfovre. Accessed June 28, 2024.