• Feature

    1. Danny Bar-Zohar, Global Program Head, Multiple Sclerosis, Novartis, Discusses Gilenya Data

    2. The Impact of Multiple Sclerosis

  • Media

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      Growing Experience with Gilenya Infographic

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      Brain Matters in MS Infographic

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      A Focus on Four Key Measures of Disease Activity Infographic

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      Advances in MS Infographic

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  • Related Documents

    1. Growing Experience with Gilenya Infographic

    2. Brain Matters in MS Infographic

    3. A Focus on Four Key Measures of Disease Activity Infographic

    4. Advances in MS Infographic

    5. About Gilenya Four Measures Fact Sheet

    6. Brain Shrinkage in MS Fact Sheet

    7. About Multiple Sclerosis Fact Sheet

    8. MS Glossary

  • Sep 12, 2014 07:10 AM RST

    New data confirm high efficacy of Gilenya® in achieving ‘no evidence of disease activity (NEDA)’ based on four key measures of MS

  • ·  A key treatment goal for patients with MS is ‘no evidence of disease activity’ (NEDA), currently defined as no relapses, MRI lesions and disability progression

    ·  Including MS-related brain shrinkage (brain volume loss) as a fourth key measure captures underlying damage that begins early in MS and is associated with loss of function

    ·  The likelihood of achieving NEDA across four key measures was more than four-times greater in patients treated with Gilenya compared to placebo


    Basel, Sept 12, 2014 Novartis announced today new analyses presented at the Joint ACTRIMS-ECTRIMS Meeting in Boston, USA, which confirmed the high efficacy of Gilenya® (fingolimod) in achieving ‘no evidence of disease activity’ (NEDA) in people with relapsing-remitting multiple sclerosis (RRMS) across four key disease measures – relapses, MRI lesions, brain shrinkage (brain volume loss) and disability progression. Specifically, patients taking Gilenya had a more than four-times greater likelihood of achieving NEDA across these four key measures (odds ratio 4.41; 95% CI 3.03-6.42; p<0.0001)1.

    NEDA is currently defined as having no relapses, MRI lesions and disability progression. These new analyses from the phase III FREEDOMS and FREEDOMS II trials reinforce the value of including brain shrinkage to the definition of NEDA. The inclusion of brain shrinkage into the NEDA definition would allow physicians to obtain a more complete assessment of a patient’s disease, including the underlying damage in MS.

    “Adopting this more comprehensive definition of NEDA, which includes brain shrinkage, allows for a more detailed assessment of disease activity in patients with MS,” said Vasant Narasimhan, Global Head of Development at Novartis Pharmaceuticals. “The data highlight the proven high efficacy of Gilenya, based on this new improved definition, across four key measures of MS.”

    The loss of physical and cognitive function in MS is driven by two types of damage that result in the loss of neurons and brain tissue - distinct inflammatory lesions (referred to as focal damage), and more widespread inflammatory neurodegenerative processes (referred to as diffuse damage). Distinct inflammatory lesions result in the loss of brain tissue and can clinically present as relapses. Widespread inflammatory damage starts early in the disease, often goes unnoticed and is also associated with loss of brain tissue and accumulated loss of function2-4. Redefining NEDA to include four key measures of MS addresses both types of damage, giving physicians a more comprehensive and balanced assessment of MS and treatment effects.

    About Multiple Sclerosis  
    Multiple sclerosis (MS) is a chronic disorder of the central nervous system (CNS) that disrupts the normal functioning of the brain, optic nerves and spinal cord through inflammation and tissue loss5. The evolution of MS results in an increasing loss of both physical (e.g. walking) and cognitive (e.g. memory) function6. This has a substantial negative impact on the approximately 2.3 million people worldwide affected by MS7, a disease that begins in early adulthood, most often between the ages of 20 and 408.

    About Gilenya
    Gilenya is the only oral disease-modifying therapy (DMT) to impact the course of relapsing-remitting MS (RRMS) with high efficacy across four key measures of disease activity: relapses, MRI lesions, brain shrinkage (brain volume loss) and disability progression9-13.

    Gilenya targets both focal and diffuse CNS damage. It prevents cells that cause focal inflammation from reaching the brain (referred to as ‘peripheral’ action), but also enters the CNS and reduces the diffuse damage by preventing the activation of harmful cells residing in the CNS (referred to as ‘central action’)14-16. It is important to address both focal and diffuse damage in RRMS to effectively impact disease activity and help preserve an individual’s physical (e.g. walking) and cognitive (e.g. memory) function.

    Gilenya has been used to treat more than 100,000 patients in a clinical trial and post-marketing setting over ten years and has a well-established safety profile.

    About Novartis in Multiple Sclerosis
    Novartis is committed to the research and development of new treatment options to offer the right treatment to the right patient at the right time, to meet patients’ needs at every stage of disease with innovative and targeted drugs.

    In addition to its ongoing development program for Gilenya in primary progressive MS (PPMS), pediatric MS and chronic inflammatory demyelinating polyneuropathy (CIDP), the Novartis MS portfolio includes Extavia® (interferon beta-1b for subcutaneous injection). Investigational compounds include BAF312 (siponimod), currently in Phase III clinical development and being developed as the first oral therapy for secondary progressive MS (SPMS). Novartis is also exploring the IL-17 pathway in MS.

  • Full Press Release

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, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 135,000 full-time-equivalent associates and sell products in more than 150 countries around the world. For more information, please visit http://www.novartis.com.


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