Gilenya (oral fingolimod) Approved in RUSSIA

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.

• Caroline says: Novartis AG announced the approval of oral fingolimod (brand name: Gilenya) in Russia. This is the FIRST approval for Gilenya (cladribine [Movectro] was also approved first in Russia a few weeks ago). Launch will be in early 2011 in Russia. An FDA decision is expected this month.
   

• Related Links:
• http://www.reuters.com/article/idUS41800+10-Sep-2010+HUG20100910…

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• BROWSE / IN current therapies fingolimod approvals
• « Movectro (oral cladribine) Approved in AUSTRALIA
• » Asthma drug albuterol improves MS when added to Copaxone