Novartis International AG / Novartis announces Russian regulatory approval for Gilenya, a once-daily oral multiple sclerosis therapy and first in a new class processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
* Russia is first country to approve Gilenya for the treatment of relapsing remitting MS, the most common form of the disease
* Gilenya is the first disease-modifying treatment in a new drug class and offers significant efficacy with a well-characterized safety tolerability profile
* Action from the US Food and Drug Administration (FDA) on Gilenya is expected in September 2010; other submissions under review worldwide Basel, September 10, 2010- The Russian health authority, the Federal Service on Surveillance in Healthcare and Social Development, has granted approval for Gilenya (fingolimod) 0.5 mg once-daily oral therapy for the treatment of relapsing remitting multiple sclerosis (MS).
Approximately 85% of patients with MS are estimated to have the relapsing remitting form at the onset of disease[1].
Russia is the first country to approve Gilenya, providing a new treatment option offering significant efficacy for patients in the convenience of an oral capsule. Novartis expects to launch Gilenya in Russia in early 2011.
In June, an advisory committee of the US Food and Drug Administration (FDA) unanimously recommended approval of Gilenya and action from the FDA is expected in September 2010. Gilenya is also under review by the European Medicines Agency (EMA) as well as other health authorities worldwide.
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