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

Biospace | May 13, 2019

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 There are currently only two scheduled for the rest of the month, with a third that has been withdrawn.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 Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR) in patients with DME.

Spotlight

Two molecules, both designed to treat the same condition, both with solubility challenges. Two biopharma companies racing to be first. Biopharma A chooses to move into trials as quickly as possible, while Biopharma B decides to address broader solubility concerns first. Who gets to market first may surprise you...download the infographic to find out.

Spotlight

Two molecules, both designed to treat the same condition, both with solubility challenges. Two biopharma companies racing to be first. Biopharma A chooses to move into trials as quickly as possible, while Biopharma B decides to address broader solubility concerns first. Who gets to market first may surprise you...download the infographic to find out.

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