- 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.”
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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.
References
[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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