Roche's Lucentis to receive FDA Priority Review for diabetic retinopathy – October 14, 2014

Roche announced last week that its supplemental Biologics License Application (sBLA) for Genentech-developed Lucentis (intravitreal ranibizumab), in the treatment of existing diabetic retinopathy, has been accepted and has received Priority Review status from the FDA. The FDA confirmed action date is February 6, 2015 and if Lucentis is approved, it will be the first eye medication available to patients with the disease. The application draws on the strong findings of the RISE (ClinicalTrials.gov Identifier: NCT00473382) and RIDE (NCT00473382) phase 3 trials, in which diabetic retinopathy patients demonstrated meaningful improvements in vision over 24 months as compared to patients with sham injections and maintained the benefits of Lucentis therapy through year three of treatment. As a reminder, the FDA grants Priority Review status to drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists. The Agency already approved Lucentis in the treatment of diabetic macular edema in August 2012, which is sold in the US by Genentech and internationally by Novartis. Per 2Q14 financials, sales experienced 4% growth for the quarter, making the drug Roche’s fourth-best selling pharma product in 2014. The Priority Review is positive news to be sure – we hope to bring you further updates just around the corner with the upcoming 3Q14 call.