FDA to review Eylea for DME

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said FDA accepted for review an sBLA for Eylea aflibercept to treat diabetic macular edema (DME). The PDUFA date is Aug. 18. The product is approved in the U.S., EU, Japan, Australia and several other countries to treat wet age-related macular degeneration (AMD). Eylea is also approved in the U.S. and Japan to treat macular edema following central retinal vein occlusion (CRVO) and in the EU to treat visual impairment due to macular edema following CRVO. Last month, partner Bayer AG (Xetra:BAYN) submitted an application to EMA to expand the European label of Eylea to include DME. ...