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'Gilenya' (Novartis) reduces

relapses and the risk of progression

in patients with multiple sclerosis

Approved in over 35 countries

MADRID, 13 Abr. (IRIN) -

A new analysis has shown that 'Gilenya' (fingolimod), marketed by Novartis, reduces relapse - compared to placebo - and the risk of disability progression in patients with relapsing-remitting multiple sclerosis (RRMS) regardless of treatment history or the severity of the disease.

The test Freedoms phase III study, presented this week at the LXIII Annual Meeting of the American Academy of Neurology (AAN), has shown that in patients treated with 0.5 mg ' Gilenya 'who had not received prior treatment with reducing the risk of disability progression, confirmed at 3 months was 37 percent compared with placebo, while in patients previously treated with other therapies, the same dose resulted in a reduction in risk of 30 percent.

in subgroups defined by age, sex and disease severity were observed consistent positive effects on the progression of disability in patients treated with 'Gilenya' compared with placebo. The disease severity index was determined by EDSS, relapse activity prior to the study, the degree of injury by magnetic resonance imaging or lesion activity at baseline.

"These data provide a deeper understanding about the effect of 'Gilenya' in the significant reduction in disability progression, observed in a wide variety of subpopulations of patients evaluated in this analysis, "as stated by the director of the Multiple Sclerosis Clinic of the University of British Columbia and trial investigator, Dr. Virginia Devonshire.

'Gilenya' licensed Mitsubishi Tanabe Pharma Corporation, is the first oral treatment of a new class of drugs called receptor modulators of sphingosine 1 phosphate (S1PR). "Gilenya 'is approved in over 35 countries including the U.S., Canada and Germany and has been studied in phase III clinical trials in over 2,500 patients with RRMS.

In MS the immune system damages the myelin sheath that protects nerve fibers in the central nervous system (CNS), which includes the brain and spinal cord. As observed in animal models, 'Gilenya' prevents many white blood cells (lymphocytes) leave the lymph nodes and are believed to cause less input into the CNS cells that attack and injure the myelin sheath. If treatment with 'Gilenya' stops for any reason, the number of lymphocytes circulating in the body increases for a few days and then gradually returns to normal after one or two months.