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FDA approves Lucentis for diabetic retinopathy

February 7, 2015 2:08 AM UTC

FDA granted approval under Priority Review to an sBLA for Lucentis ranibizumab from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) to treat diabetic retinopathy in patients with diabetic macular edema (DME). Lucentis has breakthrough therapy designation in the indication.

Lucentis already is approved in the U.S. for wet age-related macular degeneration (AMD), as well as DME and macular edema secondary to retinal vein occlusion (RVO). Genentech markets Lucentis in the U.S.; Novartis AG (NYSE:NVS; SIX:NOVN) markets it elsewhere. ...