Novartis confirms growing Gilenya® clinical and real-world experience as number of patients treated increases to over 63,000 - Multiple Sclerosis (MS) Information, and resources

Growing global evidence base reinforces consistent and sustained efficacy of first once-daily oral multiple sclerosis treatment
Up to seven years of clinical trial experience (Phase II and III) and over two years of real-world use
Gilenya is the only approved MS treatment shown to consistently decrease brain volume loss across studies with a significant effect seen as early as six months
Low rate of brain volume loss with Gilenya sustained for up to four years in Phase III studies and for up to seven years in patients after completing a Phase II study

Basel, March 26, 2013 – Latest global patient-use data show that Gilenya^® (fingolimod) has been used to treat more than 63,000 patients in clinical trials and the post-marketing setting[1].

“As the first once-daily oral MS therapy, we are pleased Gilenya has played such an important role in addressing unmet medical need in the MS community in the two years following initial approvals,” said David Epstein, Head of the Pharmaceuticals Division of Novartis Pharma AG. “Our growing experience reinforces Gilenya`s high efficacy and very good tolerability profile and Novartis remains committed to ensuring eligible patients have access to Gilenya.”

Gilenya is the only approved treatment shown to consistently decrease brain volume loss[2],[3]. Brain volume loss is the best magnetic resonance imaging (MRI) correlate of long-term disability. New data presented at the recent 65th Annual Meeting American Academy of Neurology (AAN), showed that Gilenya reduced the rate of brain volume loss by about one-third compared to interferon beta-1a IM or placebo in studies with over 3,600 patients with relapsing MS.[4] Patients from a Phase II study who remained on treatment for up to seven years experienced consistently low rates of brain volume loss[5].

Data has also shown significant efficacy with Gilenya in reducing relapses and slowing of six-month disability progression sustained at four years[6]. Nearly half of Gilenya patients were disease-free after one year of treatment[7],[8] and in the pivotal FREEDOMS study, eight out of ten patients on the approved dose remained on treatment at two years[2].

In clinical trials Gilenya exhibited a well-characterized safety profile and very good tolerability profile[2],[3].

Gilenya was approved based on the largest phase III clinical trial program in MS at the time of submission, which included a head-to-head study versus Avonex® (interferon beta-1a IM), a commonly prescribed treatment. Gilenya is now approved in 70 countries, and there is approximately 73,000 patient years of exposure[1].

Up to 2.5 million people worldwide are affected with MS[9], a neurodegenerative condition that often begins in early adulthood[10]. Around 70% of newly diagnosed patients with MS are in the prime of their lives – between 20 and 40 years of age – so most people are employed at the time of diagnosis. This can have a significant impact on careers, quality of life and families[11],[12].

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