Genzyme, a Sanofi company, has submitted a supplemental Biologics License Application (sBLA) to the FDA seeking approval of Lemtrada (alemtuzumab) for treatment of relapsing multiple sclerosis (RMS).  

Genzyme’s clinical development program for Lemtrada included two Phase 3 studies in which results for alemtuzumab were superior to Rebif (subcutaneous interferon beta-1a; EMD Serono) on clinical and imaging endpoints, including a reduction in relapse rate. In addition, some patients with pre-existing disability treated with alemtuzumab 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.

Alemtuzumab is a monoclonal antibody that selectively targets CD52 on T and B cells, resulting in the depletion of circulating cells thought to be responsible for the damaging inflammatory process in MS. This depletion is followed by a distinctive lymphocyte repopulation.

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