Genzyme, a Sanofi company , today 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(TM) (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(R) (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.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1307