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2023-02-18| Trials & Approvals

Apellis’ Syfovre Nets First FDA Approval For Geographic Atrophy

by Joy Lin
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Apellis Pharmaceuticals has announced the US FDA approval of Syfovre (pegcetacoplan injection) to treat geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD). 

Syfovre makes history as the first and only FDA-approved treatment for GA, a leading cause of blindness that affects more than one million people in the US and five million people worldwide. The drug’s approval for GA covers patients with or without subfoveal involvement and allows for a flexible dosing regimen of every 25 to 60 days.

“Today marks an extraordinary milestone for patients, the retina community, and Apellis. With its increasing effects over time and flexible dosing, we believe that Syfovre will make a meaningful difference in the lives of people with GA,” said Cedric Francois, M.D., Ph.D., co-founder and CEO of Apellis. 

Related Article: Roche’s Vision Loss Drug Clocks Two Phase 3 Wins In Macular Edema

Syfovre Slowed GA Progression by up to 36%

GA is caused by the growth of lesions in the eye which destroys the retinal cells responsible for visions. Progressive and irreversible, it takes only 2.5 years on average for GA lesions to start affecting the fovea, the area responsible for central vision, which in turn affects normal daily functioning. 

While Syfovre is designed to slow the progression of GA, it does not reverse the atrophy. The approval of the drug is based on positive two-year results from the Phase 3 Oaks and Derby studies, which showed that treatment reduced the rate of GA lesion growth compared to placebo. Increasing treatment effects were observed over time, with the greatest benefit (in Derby, 36% reduction in lesion growth with monthly treatment) occurring between months 18-24. 

The safety profile of Syfovre is well-demonstrated following approximately 12,000 injections. The most common side effects (≥ 5%) reported in patients receiving Syfovre were ocular discomfort, neovascular AMD, vitreous floaters, and conjunctival hemorrhage.

Syfovre is expected to reach the market by the beginning of March through specialty distributors and pharmacies across the US. In Europe, a marketing authorization application of the drug is under review, with a decision slated for early 2024. Apellis has also submitted the approval filing for Syfovre to Health Canada. 

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