FDA accepts Lemtrada sBLA

FDA accepted for review an sBLA from Genzyme Corp. for Lemtrada alemtuzumab to treat relapsing multiple sclerosis. The PDUFA date is in 2H13, but the exact date is not disclosed. Last August, FDA refused to file the sBLA and asked the unit of Sanofi (Euronext:SAN; NYSE:SNY) to "modify the presentation of the data sets to enable the agency to better navigate the application." An MAA for Lemtrada is under review in Europe, with a decision from EMA's CHMP expected next quarter (see BioCentury Extra, Aug. 27, 2012). ...