sBLA Accepted for Lemtrada for Relapsing Multiple Sclerosis

Genzyme announced that the FDA has accepted for review the company’s sBLA file seeking approval for Lemtrada (alemtuzumab) for the treatment of relapsing multiple sclerosis (MS).  Genzyme expects FDA action on the application in the second half of 2013.

The Lemtrada clinical development program consists of CARE-MS I and CARE-MS II (Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, randomized Phase 3 studies comparing Lemtrada to Rebif (interferon beta-1a; EMD Serono), a standard of care MS treatment, in patients with relapsing-remitting MS who were naïve to prior treatment or who had relapsed while on prior therapy, respectively.

Alemtuzumab is a monoclonal antibody that selectively targets CD52, a protein abundant on T and B cells. Treatment with alemtuzumab results in the depletion of circulating T and B cells thought to be responsible for the damaging inflammatory process in MS. Alemtuzumab has minimal impact on other immune cells.

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