Sanofi SA's Genzyme Announces LEMTRADA (Alemtuzumab) Application For MS Accepted For Review By FDA


Monday, 28 Jan 2013 01:30am EST 

Genzyme, aSanofi SA Company announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company`s supplemental Biologics License Application (sBLA) file seeking approval of LEMTRADA (alemtuzumab) for the treatment of relapsing multiple sclerosis (RMS). The Company also reported key highlights from the U.S. launch of once-daily, oral AUBAGIO (teriflunomide). The FDA has accepted for standard review the Company`s sBLA file seeking approval of LEMTRADA. Genzyme expects FDA action on the application in the second half of 2013. Genzyme has already submitted its marketing authorization application for LEMTRADA to the European Medicines Agency (EMA) and the review process is underway. The Committee for Medicinal Products for Human Use (CHMP) opinion for LEMTRADA is expected in second quarter of 2013. The LEMTRADA clinical development program includes CARE-MS I and CARE-MS II (Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis), randomized Phase III studies comparing LEMTRADA to a standard of care MS treatment, Rebif, in patients with relapsing-remitting MS who were naïve to prior treatment or who had relapsed while on prior therapy, respectively. Genzyme announced publication of results of these studies in The Lancet in November 2012. Alemtuzumab is a monoclonal antibody that selectively targets CD52, a protein abundant on T and B cells. 

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