Regeneron announced that due to ongoing labeling discussions, the U.S. FDA has issued a complete response letter regarding the supplemental Biologics License Application for EYLEA Injection in patients with wet age-related macular degeneration. 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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