PARIS (dpa-AFX) - Sanofi (SNY, SNYNF.PK) and its unit, Genzyme, reported positive top-line results from CARE-MS I, the first of two randomized, Phase 3 clinical trials comparing the investigational drug alemtuzumab to the approved multiple sclerosis therapy Rebif in patients with relapsingremitting multiple sclerosis or RRMS. Genzyme is developing alemtuzumab in MS in collaboration with Bayer HealthCare.
In the CARE-MS I trial, 2 annual cycles of alemtuzumab treatment resulted in a 55% reduction in relapse rate compared to Rebif over the two years of the study, hence satisfying the first primary endpoint, and therefore meeting the predefined protocol criteria for declaring the study a success. Statistical significance was not achieved for the second primary endpoint, time to six month sustained accumulation of disability, as compared with Rebif, the company added.
The company expects to file for U.S. and E.U. approval of alemtuzumab in MS in early 2012, and was granted fast track designation by the FDA.
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