Aubagio ™ is effective in treating multiple sclerosis
October 5th company «Sanofi» and its division «Genzyme» reported the results of clinical studies TEMSO (TEriflunomide Multiple Sclerosis Oral) drug Aubagio ™ (teriflunomide) for the treatment of multiple sclerosis. Thus, according to data published in the British Journal «The New England Journal of Medicine», the use of this drug in oral form significantly reduced the relapse rate and the rate of progression of the disease, as well as its activity, as reflected in the magnetic resonance tomogram (MRI) .
Multiple sclerosis is related to autoimmune diseases and is characterized by a lesion of the myelin sheath of nerve fibers of the brain and spinal cord of T-and B-lymphocytes, which is disruptive to the transmission of nerve impulses to the further development of sensory and motor disorders. Aubagio ™ inhibits mitochondrial enzymes in T-and B-lymphocytes by blocking cell proliferation and activity and thus preventing their damaging effect on the myelin sheath.
Clinical research TEMSO lasted 2 years and included 1088 patients with relapsing forms of multiple sclerosis in 21 countries. Aubagio ™ application in the oral form of 31% reduced risk of relapse of multiple sclerosis compared with placebo. Time to first relapse was also significantly delayed. Thus, in 53.7% of patients taking 7mg of the drug, and 56.5% of patients taking 14 mg of the drug, managed to avoid the appearance of recurrence during the study period (2 years), whereas in the placebo group this figure amounted to 45.6%.
It is still ongoing research on the effectiveness teriflunomide in patients with multiple sclerosis: TOWER, TENERE, TERACLES (as an adjunct to the appointment of beta-interferon) and TOPIC.
In August this year, the company has applied for approval to the Office of the Food and Drug Administration USA (Food and Drug Administration) and plans to apply to the European Medicines Agency (European Medicines Agency) in the I quarter 2012