Multiple Sclerosis Drug Trials Show Lemtrada Helps Prevent Relapse

MRI scan: This image shows the brain of a patient who is suffering from multiple sclerosis. MS is due to the destruction of the myelin sheaths around the axon nerve fibres of the brain and spinal cord. This is seen in the several large demyelinated lesions (black and orange)

Sanofi's multiple sclerosis drug Lemtrada helped 78 percent of patients stay relapse-free for two years, the French drug company announced at a conference Saturday.

In the study from Sanofi's Genzyme division, just 59 percent of patients given Rebif, an older drug from Merck, saw the same results. Sanofi presented the data at the 5th Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS/ACTRIMS) in Cambridge, Mass.

“CARE-MS I confirms that, in a head-to-head comparison with Rebif, disease activity is significantly reduced in patients with early relapsing-remitting multiple sclerosis treated with alemtuzumab (Lemtrada), over the first two years of observation,” said Prof. Alastair Compston, chair of the drug steering committee and head of the Department of Clinical Neurosciences at the University of Cambridge, U.K.

Multiple sclerosis, a chronic disease that attacks the central nervous system, affects 2.5 million people worldwide. Lemtrada, known generically as alemtuzumab, did not prevent the disease from becoming disabling to patients. According to Sanofi, side effects included respiratory and urinary tract infections and were mild to moderate, and similar to those of Rebif. About 18 percent of patients on Lemtrada suffering from side effects, compared to 14.4 percent of patients taking Rebif.

“Lemtrada’s robust effects over and above those of Rebif on relapses and a variety of clinical and imaging endpoints reinforces its potential as an effective treatment option for MS patients,” said Dr. David Meeker, COO for Sanofi's Genzyme division. “We look forward to the results of CARE-MS II, our second Phase III study, later this year to extend these results by confirming Lemtrada’s effects in patients with continued disease activity while receiving another MS treatment.” Another late-stage trial comparing Lemtrada with Rebif is set to begin later this year, with Sanofi planning to submit the drug for marketing approval in the first quarter of 2012.
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