Industry News — Clinical Updates
FDA Accepts Eylea Diabetic Retinopathy sBLA for Priority Review
The US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application (sBLA) for Eylea (aflibercept; Regeneron Pharmaceuticals, Inc. Tarrytown, NY) for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME). Under the Prescription Drug User Fee Act (PDUFA), the goal for a priority review is six months, for a target action date of March 30, 2015.
In September, the FDA granted Eylea its Breakthrough Therapy designation for the treatment of diabetic retinopathy in patients with DME.
Updated December 1, 2014