Novartis' First Prescription of Mayzent® (Siponimod), a Class-1 Innovative Drug for Multiple Sclerosis, Filled Nationwide in China

Shanghai, August 25, 2020 /PRNewswire/ -- On August 25, 2020, Novartis' new-generation innovative oral drug for multiple sclerosis, Mayzent^®(Generic name: Siponimod) The first prescription in China was issued. Mayzent^®It is the world’s first and only oral disease-modifying therapy (DMT) that achieves neural repair and delays disability progression in patients with relapsing multiple sclerosis (RMS).^[1]. Wanlineng^®As a Class 1 new drug, it was granted priority review status by the National Medical Products Administration (NMPA) and approved in China on May 7 this year, achieving near-simultaneous global launch. The first batch of the drug is expected to be fully implemented across more than 30 hospitals in 29 cities nationwide, including Beijing, Shanghai, and Guangzhou. Wanlineng^®Its market launch will bring more possibilities for a high-quality, vibrant life to the vast number of patients with multiple sclerosis.

Monitor Early Progression Signals to Seize the Golden Treatment Window

Multiple Sclerosis (MS) is a chronic inflammatory autoimmune disease in which the patient’s immune system attacks the myelin sheath that protects nerves, leading to impaired neurological function. 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 adults. MS is classified into three main clinical courses: Primary Progressive Multiple Sclerosis (PPMS), Relapsing-Remitting Multiple Sclerosis (RRMS), and Secondary Progressive Multiple Sclerosis (SPMS). Secondary Progressive Multiple Sclerosis is a severe disease course characterized by progressive and irreversible neurological dysfunction.

Professor Hu Xueqiang, Chair of the Neuroimmunology Branch of the Chinese Society of Immunology and Department of Neurology at the Third Affiliated Hospital of Sun Yat-sen University, stated, “As a disease with progressive course, 85% of patients have relapsing-remitting multiple sclerosis (RRMS), and over 40% of RRMS patients gradually transition to secondary progressive multiple sclerosis (SPMS) within 6–10 years.”^[2][3]. If patients experience persistent and irreversible symptoms, such as difficulty walking, reduced attention span, or inability to independently perform activities of daily living, they should remain highly vigilant, promptly communicate with their physicians, undergo disease assessment, and adopt more aggressive treatment strategies to delay disease progression, reduce relapses, and preserve greater mobility and independence in daily activities.

A patient with multiple sclerosis once said, “In the years following my diagnosis, my family’s world and mine were shrouded in gloom. I felt there was no future for me and was constantly on the verge of giving up on myself and this harsh world. The calls of familial love, medical support, and policy assistance all reminded me to hold on a little longer. The continuous approval and market launch of innovative drugs, along with encouragement from my physicians, have enabled me to achieve the ordinary life I had long dreamed of.”Perhaps by the next dawn, the world will be different.。”

Patients with relapsing multiple sclerosis need to closely monitor and identify the following early signs of progression:

Unique Neurorestorative Mechanism Halts Disability Progression

Novartis^®(Siponimod) features unique central anti-inflammatory and neurorepair mechanisms, capable of highly selectively binding to sphingosine-1-phosphate (S1P) receptors 1 and 5, thereby directly reducing inflammation within the central nervous system.^[4], promoting remyelination^[5][6], achieving neural repair.

Novartis^®The approval was based on a large-scale global Phase III clinical study in patients with relapsing forms of multiple sclerosis. The study results showed that Mayzent^®It significantly reduced the risk of confirmed disability progression (CDP) at 3 months by 21%; meanwhile, the annualized relapse rate (ARR) was reduced by 55%. Furthermore, the study demonstrated positive outcomes in areas including cognition, MRI disease activity, and brain volume loss (brain atrophy).

To benefit patients as early as possible, Wan Lineng^®Following approval, the company accelerated its nationwide rollout across major cities and hospitals in China. Professor Qiu Wei, Deputy Director of the Department of Neurology at the Third Affiliated Hospital of Sun Yat-sen University, stated: “As multiple sclerosis progresses, the potential for remyelination continually declines. Although the severity and frequency of relapses may gradually decrease or even cease, neurological damage and disability accumulate over time. Wanlineng^®Its unique mechanism acts on specific receptors in immune cells, achieving anti-inflammatory effects and promoting neural repair within the central nervous system, thereby delaying disability progression. The rapid availability of this product is a significant boon to the vast number of multiple sclerosis (MS) patients and their families, while also providing clinicians with additional therapeutic options.”

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

^[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] Scalfari A, et al. J Neurol Neurosurg Psychiatry 2014;85:67–75.;2.Gross HJ, et al. Neuropsychiatr Dis Treat. 2017;13:1349-1357.
^[3] Rovaris M, et,al. Lancet Neurol. 2006 Apr;5(4):343-54.
^[4] Gentile et al. Journal of Neuroinflammation (2016) 13:207
^[5] Tiwari-Woodruff SK, et al. Neurology. 2016;86(Suppl 16):011.
^[6] Arnold D.L, et al;ePresentation:EPR1147.EAN,2020