FDA approves Eylea for DME

FDA approved Eylea aflibercept from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) to treat diabetic macular edema (DME). The drug is already approved in the U.S. to treat wet age-related macular degeneration (AMD) and macular edema following central retinal vein occlusion (CRVO).

Eylea is also approved for wet AMD in the EU, Japan, Australia and several other countries and in Japan and the EU for macular edema following CRVO. EMA's CHMP backed approval of Eylea for DME in June. Bayer AG (Xetra:BAYN) has ex-U.S. rights to the product from Regeneron, which was up $17.67 to $322.18 on Wednesday. ...