Lucentis ranibizumab regulatory update

FDA accepted and granted Priority Review to an sBLA from Roche's Genentech unit for Lucentis ranibizumab to treat diabetic retinopathy. The PDUFA date is Feb. 6, 2015. Separately, Health Canada approved Lucentis to treat visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia. The humanized mAb fragment against VEGF-A is approved in the U.S., EU and Canada to treat wet age-related macular degeneration (AMD), diabetic macular edema (DME) and macular edema secondary to retinal vein occlusion (RVO). The drug is also approved in the EU to treat visual impairment due to CNV secondary to pathologic myopia. Genentech markets Lucentis in the U.S., while Novartis markets it elsewhere. ...