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News Breaks January 28, 2013 04:54 EDT SNY Genzyme's Lemtrada application for MS accepted for review by FDA Genzyme, a Sanofi company, announced that the FDA has accepted for review the company's supplemental Biologics License Application file seeking approval of Lemtrada for the treatment of relapsing multiple sclerosis, or MS. 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, or EMA, and the review process is underway. The Committee for Medicinal Products for Human Use opinion for Lemtrada is expected in Q2. The Lemtrada clinical development program includes Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis, or CARE-MS I and CARE-MS II, randomized Phase III studies comparing Lemtrada to a standard of care MS treatment, Rebif, in patients with relapsing-remitting MS who were naive 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. News For SNY From The Last 14 Days Check below for free stories on SNY the last two weeks. Sign up for a free trial to see the rest of the stories you've been missing. June 19, 2013 13:53 EDT SNY Sanofi to hold a conference call Subscribe for More Information June 18, 2013 08:38 EDT SNY Sanofi management to meet with JPMorgan Subscribe for More Information June 13, 2013 11:02 EDT SNY Leerink's major pharma analyst holds an analyst/Industry conference call Subscribe for More Information June 10, 2013 07:20 EDT SNY Biomed to host a conference Subscribe for More Information 07:03 EDT SNY Sanofi announces FDA approved sBLA for licensure of influenza vaccine Subscribe for More Information Sign up for a free trial to see the rest of the stories you've been missing.