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Sanofi SA's Genzyme Announces Publication of LEMTRADA (alemtuzumab) Pivotal Studies In The Lancet


Wednesday, 31 Oct 2012 06:30pm EDT 

Genzyme, a Sanofi SA company, announced the publication of results from the LEMTRADA (alemtuzumab) CARE-MS I and CARE-MS II pivotal studies in patients with relapsing-remitting multiple sclerosis (MS) in the November 1, 2012 online issue of The Lancet. In CARE-MS I and CARE-MS II, LEMTRADA was significantly more effective at reducing annualized relapse rates than the active comparator Rebif (high dose subcutaneous interferon beta-1a), and more patients on LEMTRADA were relapse-free at two years. In addition, in CARE-MS II, accumulation of disability was significantly slowed in patients given LEMTRADA vs. Rebif. Further, patients treated with LEMTRADA were significantly more likely to experience improvement in disability scores than those treated with Rebif, suggesting a reversal of disability in some patients. CARE-MS I and CARE-MS II (Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis) are randomized Phase III studies comparing the investigational treatment alemtuzumab to a standard of care MS treatment, Rebif, in patients with relapsing-remitting MS who were na├»ve to prior treatment or who had relapsed while on prior therapy, respectively. The results from these trials for LEMTRADA were superior to Rebif on clinical and imaging endpoints, including a reduction in relapse rate and are published in full in The Lancet.