Novartis receives Health Canada approval for Mayzent™ (siponimod) to treat secondary progressive multiple sclerosis with active disease

• Mayzent^TM (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 Mayzent^TM significantly reduced the risk of disease progression, including impact on physical disability³

DORVAL, QC, March 3, 2020 /CNW/ - Novartis Pharmaceuticals Canada Inc. (Novartis) is pleased to announce that Health Canada has approved Mayzent^TM (siponimod) for the treatment of adults with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features characteristic of multiple sclerosis inflammatory activity, to delay the progression of physical disability. SPMS follows a relapsing-remitting (RRMS) course of multiple sclerosis (MS) and is characterized by progressive worsening with fewer, or no relapses, and nerve damage or loss⁴. SPMS is defined as active when individuals experience relapses or there is evidence of new MRI activity⁵.

A snapshot of Secondary Progressive Multiple Sclerosis (SPMS) (CNW Group/Novartis Pharmaceuticals Canada Inc.)

"One of the top treatment goals for individuals with MS is delaying disability progression and we're delighted to deliver the first and only oral treatment proven to slow disease progression in those with active SPMS," said Dawn Bell, Chief Scientific Officer and VP Medical Affairs, Novartis Canada. "The approval of Mayzent^TM is a testament to our relentless commitment to reimagine MS treatment."

People living with SPMS experience changes in their MS symptoms with fewer or no relapses, and there can be minor remissions and plateaus⁶. Progression most frequently includes mobility issues, which may lead to the need for walking aids, bladder dysfunction, and cognitive decline⁷.

"We are pleased to see that Health Canada has approved an additional therapeutic advancement targeting progressive forms of the disease. MS is unpredictable. The more treatment options for people with MS, the more opportunities they have in managing their individual symptoms throughout their MS journey," said Dr. Pamela Valentine, President and CEO, MS Society of Canada.

"As the first oral therapy specifically approved for SPMS, Mayzent^TM may help those living with active SPMS by slowing disease progression," said Dr. Mark S. Freedman, Professor of Medicine, Department of Medicine, University of Ottawa.

About the EXPAND Study and Multiple Sclerosis
EXPAND is a randomized, double-blind, placebo-controlled Phase III study comparing the efficacy and safety of Mayzent^TM 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 Mayzent^TM (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 world^9,10. 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.

Mayzent^TM is a sphingosine-1-phosphate (S1P) receptor modulator indicated for the treatment of SPMS in adults with active disease. Mayzent^TM 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 million in 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

MAYZENT^TM is a trademark of Novartis Pharmaceuticals Canada Inc.

References

1.	Mayzent^TM Canadian Product Monograph February 20, 2020.
2.	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.
3.	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.
4.	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.
5.	National Multiple Sclerosis Society. Secondary Progressive MS (SPMS). Available at https://www.nationalmssociety.org/What-is-MS/Types-of-MS/Secondary-progressive-MS. Last accessed February 25, 2020.
6.	MS Society of Canada. What is MS – Types. Available at https://mssociety.ca/about-ms/types. Last accessed February 25, 2020.
7.	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.
8.	National MS Society. Multiple Sclerosis FAQs. Available at https://www.nationalmssociety.org/What-is-MS/MS-FAQ-s. Last accessed February 25, 2020.
9.	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.
10.	MS Society of Canada. About MS. Available at https://mssociety.ca/about-ms. Last accessed February 25, 2020.
11.	MS Society of Canada. What is MS? Available at https://mssociety.ca/about-ms/what-is-ms. Last accessed February 25, 2020.

SOURCE Novartis Pharmaceuticals Canada Inc.

For further information: Novartis Media Relations, E-mail: [email protected]; Patricia Tiramani, Communications and Patient Advocacy, [phone]; James Thayer, Golin, [email protected], [phone]