US FDA Approved First Geographic Atrophy Drug by Apellis


One of Fierce Pharma’s best three most expected drug dispatches of 2023 were likewise one of the year’s generally questionable. However, Apellis Pharmaceuticals achieved a second commercial approval for its C3 inhibitor pegcetacoplan on Friday, defying the industry’s losing trend in geographic atrophy (GA).

The first treatment for GA, an advanced stage of age-related macular degeneration that is also a leading cause of blindness, has been approved by the FDA under the name Syfovre.

In an interview prior to Syfovre’s approval, Apellis co-founder and CEO Cedric Francois described the disease as thinking of having a forest fire in your retina, where your retina slowly but certainly dies completely. There were no FDA-approved treatments for geographic atrophy prior to Syfovre. Apellis hopes that the narrative can now be revised.

However, the CEO emphasized that this is not a drug that flips the switch on day one. Syfovre’s approval was based on the drug’s capacity to slow the growth of a marker of disease progression rather than its capacity to improve or even halt central vision loss. As a result, Syfovre is not a cure.

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The drug from Apellis has a flexible dosing schedule, changing every 25 to 60 days, which could be an advantage. Further, Apellis has endeavored to guarantee its treatment works in any sort of GA patient, Francois said. Their medication can slow down these lesions, regardless of where they are located in your eye.

Positive 24-month outcomes from Apellis’ late-stage Derby and Oaks studies informed the FDA’s approval. The trials demonstrated that Syfovre had greater treatment effects over time and had a slower rate of growth of GA lesions than the placebo. According to a press release from Apellis, the greatest benefit was tracked on the high end, with a 36% reduction in lesion growth between 18 and 24 months.

Apellis said that Syfovre would be available for purchase by the beginning of March 2023. The medication will be made accessible through specialty merchants and drug stores around the US.