Novartis International AG: Novartis announces Russian regulatory approval for Gilenya®
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
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* 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. 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.
Data from one of the largest-ever Phase III clinical trial programs conducted in MS were
submitted to support the regulatory submissions. These studies provided evidence of the
efficacy of Gilenya in reducing relapses, disability progression and brain lesions in
patients with relapsing remitting MS as well as safety data. Gilenya is the first in a
new class of compounds called sphingosine 1-phosphate receptor (S1PR) modulators.
Gilenya provides selective and reversible retention of lymphocytes in lymph nodes,
preserving key immune functions and flexibility in patient management.