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). 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.

Approximately 85 per cent of patients with MS are estimated to have the relapsing remitting form at the onset of disease. Novartis expects to launch Gilenya in Russia in early 2011. Gilenya is the first disease-modifying treatment in a new drug class and offers significant efficacy with a well-characterised safety tolerability profile

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.

Novartis provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in these areas. In 2009, the Group's continuing operations achieved net sales of $ 44.3 billion, while approximately $ 7.5 billion was invested in R&D activities throughout the Group.