Novartis' oral MS therapy Gilenya receives European approval

Novartis announced Monday that the European Commission approved Gilenya (fingolimod) as the first oral multiple sclerosis treatment for use in the EU. The product is authorised for patients with highly active relapsing-remitting MS despite treatment with beta interferon, or in patients with rapidly evolving severe relapsing-remitting MS, the company said.

The decision, which followed a positive decision from the European Medicines Agency's Committee for Medicinal Products for Human Use in January, was based in part on clinical trial data that showed that Gilenya reduced relapses by 52 percent after one year compared with Biogen Idec's Avonex (interferon beta-1a). The drug also showed a 30-percent reduction in the risk of disability progression in patients with MS compared to placebo in a two-year study. According to Novartis, other data indicated that treatment with Gilenya also resulted in statistically significant reductions in brain lesion activity as measured by MRI.

Gilenya was approved by the FDA in September last year as a first-line treatment for use in patients with relapsing-remitting MS, where it has been priced at around $48,000 annually. The drug, which was licensed from Mitsubishi Tanabe Pharma, was also recently approved in Canada. Leerink Swann analyst Joshua Schimmer estimated that Gilenya could generate global sales of up to $2.9 billion annually through 2017.

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