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Novartis gains approval for Gilenya® as a first-line disease modifying oral therapy for multiple sclerosis in Switzerland a

Posted Jan 24 2011 12:00am
January 24, 2011



* Gilenya offers an alternative to frequent injections, which is a major advance for people with relapsing-remitting multiple sclerosis in Switzerland and Australia 
* Gilenya showed enhanced efficacy to interferon beta-1a IM, a commonly
prescribed treatment, reducing relapses by 52% (p<0.001) at one year
* Two-year, placebo-controlled study demonstrated that Gilenya significantly reduced the risk of disability progression


Basel, January 24, 2011 - Swissmedic, the Swiss Agency for Therapeutic Products, and the Australian Therapeutic Goods Administration (TGA) have granted approval for Gilenya(®) (fingolimod) 0.5 mg as a first-line, oral disease-modifying therapy (DMT) for the treatment of relapsing-remitting multiple sclerosis
(RRMS).


"Gilenya, with its innovative mechanism of action, can improve clinical outcomes in patients with relapsing remitting MS, " said Professor Ludwig Kappos, Neurology and Department of Research, University Hospital, Basel, Switzerland. "The significant efficacy and manageable safety profile of Gilenya make it a valuable new option for patients with relapsing-remitting MS and the physicians
who treat them."


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