EMEA approved the remedy Gilenya

EMEA approved the remedy Gilenya

The European Medicines Agency (EMEA) has approved the Gilenya (fingolimod capsules) - Europe's first medicine used for oral administration for treatment of multiple sclerosis.

The remedy is indicated for the treatment of patients with progressive remitting multiple sclerosis treated when treatment by β-interferons is insufficient or in patients with relapsing-remitting fast-progressive severe multiple sclerosis.

This decision was made on the basis of EMEA prior approval of this medicine by the Committee for Medicinal Products for human use (CMPH), obtained in January 2011 the Committee took into account data from clinical studies that the remedy Gilenya reduces  within 12 months the number of relapses in patients with multiple sclerosis by 52% compared with Avonex (interferon β-1a) made by the company «Biogen Idec».

In addition, it was shown that the application of this medicine for 2 years reduced the risk of disability of  by 30% compared with the placebo group. Use of the medication Gilenya promotes a statistically significant decrease in the rate of multiple sclerosis progression, which was proved by magnetic resonance imaging (MRT)

Gilenya  was also approved by the Food and Medicines Administration (FDA) agency in September 2010 as first-line medicines for the treatment of patients with remitting multiple sclerosis.

Gilenya is made by the pharmaceutical company Novartis.



Feb 23, 2014