12-30-2013, 07:23 PM #1
FDA Denies Approval for Lemtrada (Alemtuzumab)The U.S. Food and Drug Administration has denied approval at this time for Lemtrada™ (alemtuzumab, Genzyme, a Sanofi Company) as a therapy for relapsing MS. According to a company press release, the FDA has taken the position that one or more additional clinical trials would be needed for marketing approval of Lemtrada. The company plans to appeal the agency’s decision.
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National MS Society December 30, 2013Ashley Ringstaff
Living with MS since 8/30/10