Fast track designation granted for alemtuzumab for multiple sclerosis (MS)

Genzyme announced that the FDA has granted fast track designation to alemtuzumab for the treatment of multiple sclerosis (MS). Alemtuzumab is currently being evaluated in two pivotal multi-center, multi-national trials, known as CARE-MS (Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis). The company's CARE-MS I Phase 3 trial is a randomized study comparing alemtuzumab to the approved therapy Rebif (high-dose interferon beta-1a) in early, relapsing-remitting multiple sclerosis (RRMS) patients who have received no prior therapy. The second Phase 3 trial, CARE-MS II, is comparing alemtuzumab to Rebif in RRMS patients who had active disease while on other MS therapies.

Alemtuzumab is a recombinant, humanized monoclonal antibody (CD52). It is currently marketed as Campath in the United States as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).  

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