FDA approves Lemtrada for treatment for Multiple Sclerosis-Genzyme/Sanofi

The FDA has approved Lemtrada (alemtuzumab)on 15 November 2014 for the treatment of patients with relapsing forms of Multiple Sclerosis (MS). Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS. The FDA approval of Lemtrada is based on two pivotal randomized Phase III open-label studies comparing treatment with Lemtrada to Rebif (high-dose subcutaneous interferon beta-1a) in patients with relapsing remitting MS who were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS).