Lemtrada (Sanofi/Genzyme) filed at FDA and EMA for relapsing Multiple Sclerosis

Sanofi and Genzyme have announced that they have submitted a supplemental Biologics License Application (sBLA) to the FDA and a marketing authorization application to the European Medicines Agency seeking approval of Lemtrada (alemtuzumab) for treatment of relapsing Multiple Sclerosis (MS). 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) from Merck Serono, on clinical and imaging endpoints, including a reduction in relapse rate. In addition some patients with preexisting 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.