EMEA approved the drug Gilenya
Date: Sunday 27 March, 2011
The European Medicines Agency (EMEA) has approved the drug Gilenya (fingolimod capsules) - Europe's first drug used for oral administration for treatment of multiple sclerosis.
The drug 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 drug 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 drug 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 drug for 2 years reduced the risk of disability of by 30% compared with the placebo group. Use of the drug Gilenya promotes a statistically significant decrease in the rate of multiple sclerosis progression, which was proved by magnetic resonance imaging (MRT)
Gilenya drug was also approved by the Food and Drug Administration (FDA) agency in September 2010 as first-line drugs for the treatment of patients with remitting multiple sclerosis.
Gilenya is made by the pharmaceutical company Novartis.