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

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

July 01, 2024

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) delivered a negative opinion on the marketing authorization application (MAA) for Apellis Pharmaceuticals’ Syfovre (pegcetacoplan), intended for the treatment of geographic atrophy (GA).

CHMP's Assessment of Syfovre for Geographic Atrophy

In their assessment, the CHMP noted, “Although the studies showed that Syfovre slowed the growth of geographic atrophy lesions, this did not lead to clinically meaningful benefits for patients.” The committee underscored the necessity for treatments to significantly impact patients’ daily lives, which they found lacking in the clinical data.

Additionally, concerns were raised over the safety profile of regular intraocular injections, highlighting risks such as the development of other forms of age-related macular degeneration (AMD) or eye inflammation that could exacerbate vision impairment.

Apellis Plans for Re-Examination and Future Steps

Apellis acknowledged the dissenting opinions within the CHMP and announced their intention to request a re-examination of the application. They anticipate a final decision in the fourth quarter of 2024.

“We remain dedicated to European GA patients who currently lack viable treatment options for this debilitating condition that leads to irreversible vision loss,” remarked Jeffrey Eisele, PhD, Chief Development Officer at Apellis. “We are encouraged by the widespread support for pegcetacoplan within the European retina community and are focused on initiating the re-examination process swiftly to provide this crucial treatment to those in need.”

Notably, Syfovre (pegcetacoplan) received FDA approval in February 2023 as the first treatment sanctioned for GA by the US Food and Drug Administration, contrasting with the recent decision by the EMA’s CHMP.

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