FDA issues CRL on Eylea sBLA, so delaying decision on the new indication
US biotech Regeneron Pharmaceuticals (Nasdaq: REGN) said today that, due to ongoing labeling discussions, the US Food and Drug Administration has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for Eylea (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD).
Regeneron’s shares were barely moved in trading this morning, dipping just 1.5% to £363.24.
The sBLA was based on the second year data from the VIEW studies during which patients were treated with a modified 12 week dosing schedule (doses given at least every 12 weeks and additional doses as needed).
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