Regeneron provides regulatory update on Eylea (aflibercept) injection sBLA in wet age-related macular degeneration

Regeneron Pharmaceuticals

13 August 2018 - Regeneron Pharmaceuticals today announced that due to ongoing labelling discussions the U.S. FDA has issued a complete response letter regarding the supplemental biologics license application for Eylea in patients with wet age-related macular degeneration. 

The application 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.

Read Regeneron Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US