Sanofi SA's Genzyme Submits Applications to FDA and EMA for Approval of LEMTRADA (alemtuzumab) for Multiple Sclerosis

Genzyme, a Sanofi SA company, announced that the company has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMA) seeking approval of LEMTRADA (alemtuzumab) for treatment of relapsing multiple sclerosis (RMS). Genzyme is developing LEMTRADA in MS in collaboration with Bayer HealthCare. Genzyme’s clinical development program for LEMTRADA included two Phase III studies in which results for LEMTRADA were superior to Rebif (high dose subcutaneous interferon beta-1a) on clinical and imaging endpoints, including a reduction in relapse rate. In addition, as presented last month at the American Academy of Neurology meeting, some patients with pre-existing disability treated with LEMTRADA in the CARE-MS II trial were more than twice as likely to experience a sustained reduction in disability over two years than patients treated with Rebif. The regulatory submissions for LEMTRADA include two-year controlled efficacy and safety data from both treatment-naïve patients and those who relapsed while on therapy, with greater than five years of safety follow-up. Common adverse events associated with alemtuzumab were consistent across the Phase III program and included infusion-associated reactions and infections, which were generally mild to moderate in severity.