Novartis announces Russian regulatory approval for Gilenia

Novartis announces Russian regulatory approval for Gilenya®, a once-daily oral multiple sclerosis therapy and first in a new class
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.

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.