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CHMP backs new Eylea indication

July 27, 2013 12:43 AM UTC

EMA's CHMP issued a positive opinion recommending expanding the label of Eylea aflibercept from Bayer AG (Xetra:BAYN) to include treatment of visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO). Eylea is already approved in Europe to treat wet age-related macular degeneration (AMD).

The human fusion protein that binds all forms of VEGF-A and placental growth factor (PIGF) is approved in the U.S. for wet AMD and macular edema following CRVO, and is also approved for wet AMD in Japan, Australia, Switzerland and some Latin American countries. ...