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FDA approves Genzyme's Lemtrada

November 18, 2014 3:24 AM UTC

FDA approved Lemtrada alemtuzumab from the Genzyme unit of Sanofi (Euronext:SAN; NYSE:SNY) to treat adults with relapsing-remitting multiple sclerosis (RRMS) who have had an inadequate response to two or more prior treatments.

The agency approved the humanized mAb against CD52 with a REMS, and required that it be sold under a restricted distribution program. Genzyme resubmitted an sBLA in 2Q14 after it received a complete response letter from FDA last December. ...