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FDA refuses to file Lemtrada sBLA

August 28, 2012 12:29 AM UTC

FDA refused to file an sBLA from Genzyme Corp. for Lemtrada alemtuzumab to treat multiple sclerosis. According to Genzyme, the agency asked the company to "modify the presentation of the data sets to enable the agency to better navigate the application." The agency did not request additional data. Genzyme said it plans to resubmit the application "as soon as possible." An MAA for Lemtrada is under review in Europe. Genzyme declined to provide details.

Last year, Sanofi (Euronext:SAN; NYSE:SNY) acquired Genzyme for about $20.1 billion, plus a $14 contingent value right, $13 of which is devoted to milestones for Lemtrada in MS. The CVR, which trades on NASDAQ under the ticker symbol GCVRZ, was down $0.07 to $1.39 on Monday. ...