Apellis’ Syfovre Receives the US FDA’s Approval as the First Treatment for Geographic Atrophy
- The US FDA has approved Syfovre (pegcetacoplan injection) for GA secondary to AMD. The approval was based on the P-III (OAKS) & (DERBY) studies evaluating the efficacy & safety of Syfovre
- The results showed a reduction in the rate of GA lesion growth vs sham and demonstrated increasing treatment effects over time with the greatest benefit, ~36% reduction in lesion growth with monthly treatment in (DERBY) b/w 18-24mos.
- The company launched the patient support program i.e., ApellisAssist incl. insurance support, financial assistance, disease education & ongoing product support for eligible patients. The MAA for Syfovre is currently under EMA’s review with an expected decision in early 2024
Ref: GlobeNewswire | Image: Apellis
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