Sanofi Reports Positive Results from Alemtuzumab Phase 3 Study

The company expects to file for U.S. and E.U. approval of alemtuzumab in MS in early 2012.

Sanofi and its subsidiary Genzyme announced 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? (high dose subcutaneous interferon beta-1a) in patients with relapsing-remitting multiple sclerosis (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 percent reduction in relapse rate compared to Rebif? over the two years of the study (p<0.0001), hence satisfying the first primary endpoint, and therefore meeting the predefined protocol criteria for declaring the study a success. Statistica