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Eylea approved for BRVO ahead of PDUFA

October 7, 2014 2:24 AM UTC

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said FDA on Monday approved an sBLA for Eylea aflibercept ophthalmic solution to treat macular edema following retinal vein occlusion including branch retinal vein occlusion (BRVO). The PDUFA date was Oct. 23.

The human fusion protein that binds all forms of VEGF-A and placental growth factor ( PGF; PlGF) is already approved in the U.S., EU and other countries to treat wet AMD, DME and macular edema following CRVO. Eylea is under EMA review in the BVRO indication. ...