Novartis Announces China Approval of Mayzent® (Siponimod), the First and Only Oral Therapy for Active Secondary Progressive Multiple Sclerosis

• China's National Medical Products Administration Approves Mayzent® (Siponimod) for the Treatment of Relapsing Forms of Multiple Sclerosis in Adults

• Currently the world’s first and only oral disease-modifying therapy (DMT) for the treatment of active secondary progressive multiple sclerosis (SPMS)1

• Up to 50–60% of patients with relapsing-remitting multiple sclerosis (RRMS) will progress to active secondary progressive multiple sclerosis (SPMS). Mayzent® (siponimod) can effectively slow disability progression and cognitive decline in patients.

Novartis China announced that the National Medical Products Administration has approved Mayzent® (siponimod) for the treatment of adult patients with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (CIS), relapse-remitting disease (RRMS), and active secondary progressive disease (SPMS). Over time, up to 50–60% of patients with relapse-remitting multiple sclerosis (RRMS) will progress to SPMS. Mayzent® (siponimod) is currently the first and only oral disease-modifying therapy (DMT) approved globally for the treatment of active secondary progressive multiple sclerosis. Early initiation of treatment can effectively slow the progression of disability and cognitive decline in patients.

Ms. Zhang Ying, President of Novartis China, stated, “Shaping the future of medicine is Novartis’ mission. Thanks to the Chinese government’s determination and decisive actions in accelerating innovative drugs, I am delighted that less than a year after Gilenya® (fingolimod) was approved in China last July, Novartis has secured marketing approval for another breakthrough therapy in the field of multiple sclerosis: Mayzent® (siponimod). Patients with active secondary progressive multiple sclerosis often face a higher risk of irreversible disability, bear a heavy disease burden, and have greater unmet treatment needs. The arrival of Mayzent® (siponimod) is expected to bring renewed hope to these patients. In the future, Novartis will continue to introduce more innovative multiple sclerosis treatment solutions to China, benefiting patients.”

60% of RRMS patients will progress to SPMS

Lack of Effective Treatment Options for Patients

Multiple Sclerosis (MS) is a chronic inflammatory autoimmune disease in which the patient’s immune system attacks the myelin sheath that protects nerves, resulting in neurological impairment. Most patients experience their first symptoms between the ages of 20 and 40, making MS one of the most common causes of neurological disability in young and middle-aged adults. The prevalence of MS in China is approximately 7.5 per 100,000, affecting more than 30,000 patients. Currently, MS is classified into three main clinical courses: Primary Progressive Multiple Sclerosis (PPMS), Relapsing-Remitting Multiple Sclerosis (RRMS), and Secondary Progressive Multiple Sclerosis (SPMS).

Approximately 85% of multiple sclerosis (MS) cases are classified as relapsing-remitting multiple sclerosis (RRMS). Without effective treatment, about 50–60% of patients with RRMS will progress to secondary progressive multiple sclerosis (SPMS), with the earliest progression occurring within five years. Compared with RRMS, SPMS is associated with more severe functional impairment. Patients may experience symptoms such as difficulty walking, cognitive impairment, visual and upper limb dysfunction, depression, pain, fatigue, and urinary incontinence, which significantly impact daily life and work.

Mayzent® is the first proven in SPMS patients

Oral DMT Drug with Unique Therapeutic Efficacy

The etiology of multiple sclerosis (MS) remains unknown. Currently, MS is considered a disease resulting from the interplay of multiple factors, which impair the normal functions of the brain, optic nerves, and spinal cord through inflammatory and immune-mediated mechanisms. Mayzent® (siponimod) is a next-generation, selective sphingosine-1-phosphate (S1P) receptor modulator. Siponimod features a unique dual mechanism: on one hand, it prevents lymphocytes from entering the central nervous system (CNS) in patients with MS, thereby exerting anti-inflammatory effects; on the other hand, it directly acts within the CNS to promote remyelination and provide neuroprotective benefits.

The approval of Mayzent® is based on the groundbreaking data from the Phase III EXPAND study, the largest randomized, double-blind, placebo-controlled clinical trial conducted in a broad population of patients with secondary progressive multiple sclerosis (SPMS) (1,651 SPMS patients with an Expanded Disability Status Scale [EDSS] score of 3.0–6.5), which evaluated the long-term efficacy and safety of Mayzent® in SPMS patients. The study results demonstrated that Mayzent® significantly reduced the risk of 3-month confirmed disability progression (a 21% reduction versus placebo, P=0.013; a 33% reduction versus placebo in patients with relapse activity within 2 years prior to screening, P=0.0100). Furthermore, Mayzent® significantly reduced the risk of 6-month disability progression (a 26% reduction versus placebo, P=0.0058) and lowered the annualized relapse rate by 55%. Additionally, positive outcomes were observed in areas including cognition, MRI disease activity, and brain volume loss (brain atrophy).

In April this year, Novartis also published the latest data in the supplement to Neurology, the journal of the American Academy of Neurology. The study showed that SPMS patients who continuously received Mayzent® treatment had a lower risk of disability progression and cognitive decline compared to those who delayed Mayzent® treatment. These clinical benefits persisted for 5 years, demonstrating the advantage of early initiation of treatment4.

In the field of multiple sclerosis (MS), Novartis boasts a robust portfolio. In the future, more innovative drugs will be successively approved and launched, helping MS patients access more suitable treatment options.

Reference

1. National MS Society Brochure. Disease Modify Therapies for MS.  http://www.nationalmssociety.org/NationalMSSociety/media/MSNationalFiles/Brochures/Brochure-The-MS-Disease-Modifying-Medications.pdf 

2. Antel J et al. Acta Neuropathol 2012; 123:627-38

3. Incidence and Prevalence Database (IPD)

4. Kappos L, et al. Long-term Efficacy and Safety of Siponimod in Patients with SPMS: EXPAND Extension Analysis up to 5 Years. Neurology. 2020; 94 (15 Supplement).

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