Penn spinout Apellis Pharmaceuticals, Inc. received U.S. Food and Drug Administration (FDA) approval for their drug SYFOVRE™ (pegcetacoplan injection). SYFOVRE, which treats geographic atrophy (GA) secondary to age-related macular degeneration (AMD), is the first and only FDA-approved treatment for GA, a leading cause of blindness that impacts more than one million people in the U.S. and five million worldwide.
The FDA approval of SYFOVRE is based on positive results from the Phase 3 OAKS and DERBY studies conducted by Apellis at 24 months across a broad and representative population of patients. In these studies, SYFOVRE was found to reduce the rate of GA lesion growth compared to sham and demonstrated increasing treatment effects over time, with the greatest benefit occurring between months 18-24.
In the press release, Cedric Francois, M.D., Ph.D., co-founder and chief executive officer of Apellis, said: “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 chief executive officer of Apellis.
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