Sep 12, 2019
  • New post hoc statistical analysis of the pivotal EXPAND study at ECTRIMS shows that Mayzent® (siponimod) can help patients keep their mobility for over four years longer on average *[1]
  • Further EXPAND analyses demonstrate Mayzent also significantly reduced grey matter volume loss at one and two years, a key driver of disability progression and cognitive decline in patients with SPMS [2],[3]
  • Additional pre-clinical data show Mayzent may have re-myelination properties, which support the regeneration of damaged myelin in the central nervous system, potentially preventing further neurodegeneration [4]
  • Mayzent, the only treatment for active SPMS approved by the US Food and Drug Administration (FDA) with proven efficacy in a pivotal study of a representative SPMS population, is currently under review by the European Medicines Agency (EMA)

Basel, September 12, 2019 – Novartis today presented new data on Mayzent® (siponimod) at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Stockholm, Sweden. These data, which included additional post hoc analyses from the Phase III EXPAND trial, build on the existing clinical evidence that Mayzent has a significant impact on physical and cognitive abilities of patients living with secondary progressive multiple sclerosis (SPMS) [5],[6].

“Delaying disability progression and slowing declining cognitive function can mean maintaining independence for longer and matters a lot to people living with MS and physicians” said Norman Putzki, MD PhD, Global Program Head, Novartis Pharmaceuticals. “We are excited that these data once again underline the true value of Mayzent, the first and only oral treatment proven to slow disease progression in SPMS. Mayzent crosses the blood brain barrier, selectively targets S1P1 & S1P5 receptors and tackles smoldering inflammation at the source. Mayzent expands possibilities for patients with MS, resulting in fewer relapses, reduced lesion volume increase, improved cognitive processing speed, reduced grey matter volume loss and delayed time to wheelchair. Our ongoing efforts into advancing the science bear testament to our relentless commitment to reimagine MS treatment.”

This media update contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this media update, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this media update will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update as a result of new information, future events or otherwise.

About Novartis

Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach more than 750 million people globally and we are finding innovative ways to expand access to our latest treatments. About 108,000 people of more than 140 nationalities work at Novartis around the world. Find out more at

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* As measured by prolonged time to wheelchair dependence for patients with SPMS by an average of 4.3 years versus placebo.


[1]   Vermersch P, Gold R, Kappos L, et al. Siponimod Delays the Time to Wheelchair in Patients with SPMS: Results from the EXPAND study. 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), September 2019.
[2]   Arnold D, Giovannoni G, Cree B, et al. Relationship Between Grey Matter Atrophy, Disability and Cognition in Patients with Secondary Progressive Multiple Sclerosis: Analysis from the EXPAND Study. 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), September 2019.
[3]   Arnold D, Fox R, Bar-Or A, et al. Effect of Siponimod on Cortical Grey Matter and Thalamic Volume in Patients with Secondary Progressive Multiple Sclerosis - Results of the EXPAND Study. 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), September 2019.
[4]   Martin E, Urban B, Beerli C, et al. Siponimod (BAF312) is a Potent Promyelinating Agent: Preclinical Mechanistic Observations. 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), September 2019.
[5]   Kappos L, Cree B, Fox R, et al. Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomized, phase 3 study. Lancet. 2018:391(10127):1263-1273.
[6]   Benedict R, et al. Impact of Siponimod on Cognition in Patients With Secondary Progressive Multiple Sclerosis: Results From Phase 3 EXPAND Study. Oral presentation. AAN 2018.

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