Delay in US for sBLA for Eylea for patients with wet age-related macular degeneration (wet AMD) 12 week dosing schedule.- Regeneron + Bayer
Regeneron Pharmaceuticals, Inc.y announced that due to ongoing labeling discussions the FDA 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).
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). Regeneron expects to complete these discussions and receive a final FDA action within approximately two months.
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