Novartis' Mayzent, the First Oral Therapy for Secondary Progressive Multiple Sclerosis (SPMS), Now Available in China with Demonstrated Benefits in Cognition and Disability Progression Delay

September 12, 2020 /Bio ValleyBIOON/ --Novartis(Novartis) recently at the 8th joint ACTRIMS-ECTRIMSMeetingAt MSVirtual2020, the analysis results of the Phase IIIb EXCHANGE trial and the Phase III EXPAND trial evaluating Mayzent (Chinese brand name: Wanlineng®; generic name: siponimod) for the treatment of secondary progressive multiple sclerosis (SPMS) were announced. The data indicated that Mayzent is a safe therapeutic option.It can improve cognitive function and reduce the risk of disability progression; earlier treatment yields greater benefits.

In May this year, Mayzent® (siponimod) was approved for marketing in China for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome (CIS), relapsing-remitting disease (RRMS), and active secondary progressive disease (SPMS). Over time, up to 50–60% of patients with RRMS will progress to SPMS.Mayzent (万立能®) is a next-generation, selective sphingosine-1-phosphate (S1P) receptor modulator., isThe World’s First Oral Disease-Modifying Therapy (DMT) Approved for the Treatment of SPMS, early initiation of treatment can effectively slow the progression of disability and cognitive decline in patients.

EXCHANGE is a prospective, 6-month, open-label Phase IIIb study evaluating the safety and tolerability of switching patients with relapsing multiple sclerosis (RMS), including active secondary progressive multiple sclerosis (SPMS), from other disease-modifying therapies (DMTs) to Mayzent. The interim analysis included 112 patients eligible for the safety analysis from 42 centers in the United States, further reinforcing the safety and tolerability profile of Mayzent.

EXPAND was a randomized, double-blind, placebo-controlled Phase III study comparing the efficacy and safety of Mayzent versus placebo in patients with secondary progressive multiple sclerosis (SPMS) across varying levels of disability. The results demonstrated that early treatment with Mayzent delayed disability progression and improved cognitive function.

Post-hoc EXPAND analyses demonstrated improvements in cognitive processing speed in patients with active and non-active secondary progressive multiple sclerosis (SPMS) treated with Mayzent. Furthermore, an increased likelihood of clinically relevant improvement was observed in patients with active disease. Patients with active SPMS who received early and continuous Mayzent treatment had a lower risk of disability progression and cognitive decline compared to those who delayed Mayzent treatment. Subgroup analyses showed that, in patients with active SPMS,The value of early treatment with Mayzent lies in:Its positive effects on disability, cognitive processing speed, and relapse prognosis can last for up to 5 years.

NovartisNorman Putzki, Global Head of Development for Neuroscience, stated, “One of the primary goals for patients with multiple sclerosis is to maintain independence for as long as possible. The data announced today further confirm that Mayzent is a suitable option for patients to safely switch from other therapies, owing to its beneficial effects on cognitive function and delaying disability progression. Mayzent brings hope to patients striving to achieve this important goal.”

Although the course of multiple sclerosis (MS) is unique for each patient and influenced by various factors, including the use of disease-modifying therapies (DMTs) for MS, it is estimated that up to 80% of patients with relapsing-remitting multiple sclerosis (RRMS) will eventually transition to secondary progressive multiple sclerosis (SPMS). Therefore, initiating treatment early to slow disability progression is crucial for patients. Disability progression most commonly includes, but is not limited to, impacts on mobility, which may lead to the need for walking aids or wheelchairs, bladder dysfunction, and cognitive decline.

The active pharmaceutical ingredient of Mayzent is siponimod, a next-generation, selective sphingosine-1-phosphate (S1P) receptor modulator that selectively binds to S1P1 and S1P5 receptors. Upon binding to the S1P1 receptor subtype on lymphocytes, siponimod prevents lymphocytes from egressing from lymph nodes, thereby blocking their entry into the central nervous system (CNS) of patients with multiple sclerosis (MS) and exerting anti-inflammatory effects. Furthermore, siponimod can penetrate the CNS and directly bind to S1P5 and S1P1 receptor subtypes on specific cells within the CNS (oligodendrocytes and astrocytes), promoting remyelination and preventing inflammation.

Mayzent was approved in the United States in March 2019FDAApproved for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), including active secondary progressive multiple sclerosis (SPMS), relapsing-remitting multiple sclerosis (RRMS), and clinically isolated syndrome (CIS). In the European Union, Mayzent was approved in January 2020 for the treatment of adult patients with SPMS, specifically those with active disease evidenced by relapses or inflammatory activity on imaging (e.g., gadolinium-enhancing T1 lesions or active, new, or enlarging T2 lesions), to delay the progression of physical disability.

It is worth noting that Mayzent is the first oral medication approved for patients with active secondary progressive multiple sclerosis (SPMS), and the first therapeutic agent approved for this patient population in nearly 15 years. The drug has been proven to effectively delay disease progression, addressing a significant unmet medical need among patients with active SPMS.

Novartis is committed to bringing Mayzent to patients worldwide, with regulatory filings currently underway in multiple countries. The success of Mayzent hasNovartisThis is crucial, as the company’s other blockbuster oral multiple sclerosis (MS) drug, Gilenya, with annual sales of $3 billion, is facing increasingly fierce competition. The industry holds a very optimistic view of Mayzent’s commercial prospects, with analysts predicting that its peak annual sales after launch could reach as high as $3 billion. (Bioon.com)

Original Source: Novartis data show early treatment with Mayzent® (siponimod) delays disability progression and shows benefits in cognitive performance in patients with secondary progressive multiple sclerosis (SPMS)