Mayzent

Mayzent (Siponimod) is a selective sphingosine 1-phosphate (S1P) receptor modulator that selectively binds to S1P1 and S1P5 receptors. When binding to the S1P1 subtype receptor on lymphocytes, siponimod prevents lymphocytes from leaving lymph nodes and thereby preventing them from entering the central nervous system (CNS) of MS patients, exerting an anti-inflammatory effect. In addition, siponimod can also enter the CNS and directly bind to the S1P5 and S1P1 subtype receptors on specific cells (oligodendrocytes and astrocytes) to promote remyelination and prevent inflammation.

In March 2019, Mayzent was approved by the FDA in the United States 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).

Mayzent is the first treatment approved specifically for patients with active SPMS in the United States in the past 15 years.

January 20, 2020 Novartis announced that the European Commission (EC) has approved Mayzent (siponimod) for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease as evidenced by imaging features of relapsing or inflammatory activity (e.g., Gd-enhancing T1 lesions or active, new or expanding T2 lesions).

This approval makes Mayzent the first and only oral drug approved for patients with active SPMS in Europe.

On May 8, 2020, the marketing application for Siponimod tablets submitted by Novartis Pharmaceuticals in China was approved by the China State Food and Drug Administration for the treatment of relapsing multiple sclerosis in adults.

The results of the Phase III EXPAND study show that siponimod can significantly reduce the risk of confirmed disability progression (CDP) in SPMS patients by 21% at 6 months compared with placebo; among patients with relapse activity within two years before screening, siponimod can reduce the risk of CDP by 33% compared with placebo.

At the same time, siponimod significantly reduced the patient's 6-month CDP risk by 26% and the annual relapse rate (ARR) by 55% compared with placebo.

In addition, the EXPAND study showed that siponimod has significant advantages in other related indicators of MS disease activity, including cognition, MRI disease activity, and brain volume reduction (brain atrophy).

In terms of safety, the most common adverse reactions (incidence greater than 10%) include headache, hypertension and elevated transaminases.