FDA approves updated label for Eylea in wet-AMD

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).

The sBLA was based on second-year data from the Phase III VIEW 1 and 2 trials in which patients with wet AMD were treated with a modified 12-week dosing schedule (doses given at least every 12 weeks, and additional doses as needed). These data are now included in the updated EYLEA label.