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FDA Action Alert: Regeneron, Bristol-Myers Squibb and Incyte

May 13, 2019 / Mark Terry

May has been a fairly slow month for approvals by the U.S. Food and Drug Administration (FDA). There are currently only two scheduled for the rest of the month, with a third that has been withdrawn. Let’s take a look. Regeneron’s Eylea for Diabetic Retinopathy Regeneron Pharmaceuticals has a target action date of May 13 for its supplemental Biologics License Application (sBLA) of Eylea (aflibercept) injection for diabetic retinopathy (DR). DR is the leading cause of vision loss in diabetic patients. The sBLA submission was built on data from the Phase III PANORAMA trial that studied the drug as a treatment for moderately severe to severe non-proliferative diabetic retinopathy (NPDR) without diabetic macular edema (DME). The company announced positive topline data from PANORAMA in March 2018. Eylea is a vascular endothelial growth factor (VEGF) inhibitor. The drug has already been approved in the U.S. for Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edem...