Novartis receives Health Canada approval for Mayzent (siponimod) to treat secondary progressive multiple sclerosis with active disease?
- MayzentTM?(siponimod) is the first oral treatment approved for people living with secondary progressive multiple sclerosis (SPMS) with active disease, and the first treatment approved for SPMS with active disease in almost 15 years1
- Most people living with relapsing remitting MS (RRMS) will develop SPMS2
- Approval is based on the Phase III EXPAND trial, the largest controlled clinical study of people living with SPMS, showing MayzentTM?significantly reduced the risk of disease progression, including impact on physical disability3
EXPAND is a randomized, double-blind, placebo-controlled Phase III study comparing the efficacy and safety of MayzentTM?versus placebo in people with SPMS. The study included 1,651 people with a diagnosis of SPMS from 31 countries, including 47 participants in?Canada3. Those enrolled in EXPAND were representative of a typical SPMS population: at study initiation, participants had a mean age of 48 years, had been living with MS for approximately 16 years and more than 50% had a median Expanded Disability Status Scale (EDSS) score of 6.0 and relied on a walking aid3. EXPAND included a subset of patient with active disease (n=779), defined as patients with relapses in the two years prior to the study and/or presence of gadolinium-enhancing T1 lesions at baseline. The baseline characteristics were similar except for signs of activity compared to the overall population. About?Multiple?Sclerosis and MayzentTM?(siponimod)
MS is a chronic, often disabling disease that attacks the central nervous system (CNS), made up of the brain, spinal cord and optic nerve8. It?affects?over 77,000?Canadians ? one of the highest prevalence rates in the world9,10.?MS is currently classified as an autoimmune disease of the CNS8. The disease attacks and destroys myelin ? the protective fatty insulation around the nerve fibres of the brain and spinal cord ? interrupting signals between the brain and the body8. There are?three?main?forms?of?MS:?RRMS?(the?most?common?form of the?condition?at?diagnosis), SPMS?and?primary?progressive?MS?(PPMS)11. The disease progression rate, severity, and specific symptoms of MS are unpredictable and vary from one person to another8. MayzentTM?is a sphingosine-1-phosphate (S1P) receptor modulator indicated?for?the?treatment?of SPMS?in adults with active disease.?MayzentTM?targets two separate receptors involved in the immune response of the CNS3. Siponimod binding to S1P1 receptors on lymphocytes prevents lymphocyte from egressing the lymph nodes?and as a consequence, from entering the CNS of patients with MS. About Novartis Pharmaceuticals Canada??
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. In 2018, the company invested?$52 millionin research and development in?Canada. Located in?Dorval, Quebec, Novartis Pharmaceuticals Canada Inc. employs approximately 1000 people in?Canada?and is an affiliate of Novartis AG, which provides innovative healthcare solutions that address the evolving needs of patients and societies. For further information, please consult?www.novartis.ca. 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 109,000 people of more than 145 nationalities work at Novartis around the world. Find out more at?www.novartis.com MAYZENTTM?is a trademark of Novartis Pharmaceuticals Canada Inc. References
1. |
MayzentTM?Canadian Product Monograph February 20, 2020. |
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Skoog B, Runmarker B, Winblad S, Ekholm S, Andersen O. A representative cohort of patients with non-progressive multiple sclerosis at the age of normal life expectancy. Brain. 2012;135(3); 900?911. |
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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. Published online March 22, 2018.?http://dx.doi.org/10.1016/S0140-6736(18)30475-6. |
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Cedars-Sinai. Secondary Progressive Multiple Sclerosis. Available at?https://www.cedars-sinai.edu/Patients/Health-Conditions/Secondary-Progressive-Multiple-Sclerosis.aspx. Last accessed February 25, 2020.?? |
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MS Society of Canada. What is MS ? Types. Available at?https://mssociety.ca/about-ms/types. Last accessed February 25, 2020. |
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Gross H, Watson C. Characteristics, burden of illness, and physical functioning of patients with relapsing- remitting and secondary progressive multiple sclerosis: a cross-sectional US survey. Neuropsychiatric Disease and Treatment. 2017;13:1349-1357. |
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National MS Society. Multiple Sclerosis FAQs. Available at?https://www.nationalmssociety.org/What-is-MS/MS-FAQ-s. Last accessed February 25, 2020. |
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Government of Canada. Multiple Sclerosis in Canada. Available at?https://www.canada.ca/en/public-health/services/publications/diseases-conditions/multiple-sclerosis-infographic.html. Last accessed February 24, 2020.? |
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MS Society of Canada. About MS. Available at?https://mssociety.ca/about-ms. Last accessed February 25, 2020. |
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MS Society of Canada. What is MS? Available at?https://mssociety.ca/about-ms/what-is-ms. Last accessed February 25, 2020.? |