Lucentis ranibizumab regulatory update

The U.K.'s NICE issued final guidance recommending Lucentis ranibizumab from Novartis to treat visual impairment due to diabetic macular edema (DME) in patients with central retinal thickness >=400 µm. Novartis also agreed to provide the drug at a discount under a patient access scheme. The final guidance is in line with a final appraisal determination (FAD) issued in January. Last year, NICE issued draft guidance recommending Lucentis for DME patients with central retinal thickness >=400 µm, citing Novartis' submission of a revised patient access scheme and updated analyses showing the drug is most effective in patients with thicker retinas (see BioCentury, Oct. 8, 2012 & Jan. 7, 2013). The humanized mAb fragment against VEGF-A is approved in the EU to treat wet age-related macular degeneration (AMD), DME and macular edema secondary to retinal vein occlusion (RVO). ...