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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