• Real-world evidence showed superiority of Novartis' Gilenya® to reduce MS relapse rates compared to interferons or glatiramer acetate

    • Real-world data showed Gilenya reduced the annualized relapse rate and risk of relapse by around 50% versus interferons or glatiramer acetate

    • Reducing the frequency and probability of future relapses in patients with MS is a key treatment goal, as relapses can significantly advance an individual's level of disability

    • Recovering from a relapse can take weeks or months for a patient with MS, and approximately half of all relapses may leave lasting effects

    Basel, October 3, 2013  Novartis announced today findings from an international multiple sclerosis (MS) registry and a US health claims data base which showed the real-world superiority of Gilenya® (fingolimod) in reducing risks of relapses compared to standard therapies1-3. These data confirm the positive results seen in clinical trials with Gilenya, and were presented at the ongoing 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark.

    Relapses can make life unpredictable for patients with MS and they can potentially significantly advance an individual’s level of disability
    4. MS patients’ clinical outcomes are regularly assessed and switching between disease-modifying therapies (DMTs), to reduce the rate or likelihood of a relapse, is a frequent treatment strategy.

    "Controlling relapses and preventing disability are key treatment goals for patients with MS." said
    David Epstein, Division Head of Novartis Pharmaceuticals. "It is encouraging to see that the benefits of Gilenya, which is the only oral disease modifying treatment proven in clinical studies to have a superior relapse reduction compared to an active comparator, are now confirmed in the real-world setting."

    The ‘MSBase study’, a global, longitudinal, observational registry for MS involving 60 centers in 26 countries and US administrative claims data from the ‘IMS PharMetrics Plus
    TM Database’ were interrogated for information on the impact on MS relapses of switching to either oral Gilenya or to one of the standard injectable therapies – an interferon or glatiramer acetate. Collectively, analysis of patient data from these large, real-world databases (416 patients from MSBase and 933 patients from the IMS PharMetrics PlusTM Database) showed that treatment with Gilenya reduced the annualized relapse rate and risk of relapse by approximately 50% compared to therapy with an interferon or glatiramer acetate treatment1-3. They also showed that even amongst patients with MS who have a history of relapse, switching to Gilenya was associated with significant and clinically meaningful reductions in the number of relapses and the probability of experiencing a relapse compared to switching to an interferon or glatiramer acetate1,3.

    Following first approvals in 2010, once daily oral Gilenya is now available in more than 75 countries and more than 71,000 patients have been treated in both the clinical trial and post-marketing settings with over 87,000 patient years of exposure
    5.

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About Novartis

Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 131,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit www.novartis.com.


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