• FDA Issues Complete Response Letter For Regeneron’s SBLA For EYLEA

    • August 14, 2018
    • Posted By : admin
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    Regeneron Pharmaceuticals, Inc. (REGN) 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 (aflibercept) Injection in patients with wet age-related macular degeneration. Regeneron expects to complete these discussions and receive a final FDA action within approximately two months.

    EYLEA (aflibercept) Injection is a vascular endothelial growth factor inhibitor formulated as an injection for the eye. EYLEA is currently approved in wet age-related macular degeneration for every four- or eight-week dosing intervals after three initial monthly doses. Regeneron and Bayer AG collaborate on the global development and commercialization of EYLEA.

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