FDA approves updated label for Eylea in wet-AMD

17 August 2018

Following a setback just a few days ago, when the US Food and Drug Administration issued a complete response letter (CRL) to a supplemental Biologics License Application (sBLA) for Eylea (aflibercept) injection due to ongoing labeling discussions, the FDA has now come up with a positive decision.

The drug’s maker Regeneron Pharmaceuticals (Nasdaq: REGN) today announced that the FDA has approved a supplemental sBLA for Eylea Injection in patients with wet age-related macular degeneration (wet-AMD).

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