French drug maker Sanofi's Lemtrada (alemtuzumab) achieved one of two primary endpoints in a Phase 3 trial.
Top-line results of a trial comparing the effectiveness of Lemtrada (alemtuzumab) in treating relapse-remitting multiple sclerosis (RRMS) with that of the established treatment Rebif were mixed. The results of the two-year Phase 3 trial were released yesterday by Sanofi, the maker of Lemtrada and France’s largest pharmaceutical company.
The trial included 581 early, active RRMS patients who had received no previous therapy for their condition. Patients who took alemtuzumab experienced a 55% reduction in relapse rate compared with those who took Rebif, satisfying the trial’s first primary endpoint. However, the trial failed to achieve statistical significance for its second primary endpoint, which involved preventing disability. (Of patients on alemtuzumab, 8% experienced increased disability, compared with 11% on Rebif.)
Common side effects for patients in the trial on alemtuzumab included headache, rash, fever, nausea, flushing, hives, and chills. Infections also increased, including in the upper respiratory and urinary tract and oral herpes. However, no patient taking alemtuzumab left the study due to adverse effects. Sanofi plans to run another trial that will test the effectiveness of alemtuzumab on RRMS patients who have received other treatments without success.
Full results of the first trial are still being analyzed and will be presented later this year. The company plans to file for US and EU approval of alemtuzumab as a treatment for multiple sclerosis early next year and has been granted fast-track designation by the FDA. The drug has been available in the US since 2007 as a treatment for leukemia, sold under the name Campath.
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