Regeneron's Eylea gets breakthrough designation

FDA granted breakthrough therapy designation to Eylea aflibercept from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) to treat diabetic retinopathy in patients with diabetic macular edema (DME). Regeneron plans to submit an sBLA for the vascular endothelial growth factor A (VEGF-A) inhibitor in the indication by year end.

Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. To support the designation, preliminary clinical evidence must show the compound offers substantial improvement over therapies approved for the indication or over placebo on clinically significant endpoints when approved therapies do not exist. ...