Novartis' Mayzent (siponimod) Approved by FDA for Adult Relapsing Forms of Multiple Sclerosis Including Active Secondary Progressive Disease

VCBeat New Medicine (biobeat1) learned that on March 26, 2019,FDA(U.S. Food and Drug Administration) ApprovalMayzent（siponimod) tablets for the treatment of relapsing multiple sclerosis in adults (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.Mayzentis the first to obtainFDAApproval of drugs that can effectively alleviate secondary progressive multiple sclerosis.

“Multiple sclerosis can have a profound impact on an individual's life,”FDADirector, Division of Neurology Products, Center for Drug Evaluation and ResearchBilly DunnThe doctor said.“We are committed to continuing our collaboration with companies developing alternative treatment options for patients with multiple sclerosis.”

Multiple Sclerosis (MS) is a chronic inflammatory autoimmune disease of the central nervous system. The primary pathogenic mechanism involves disrupting communication between the brain and the rest of the body. Most people20To40first onset between the ages ofMSassociated symptoms.MSIt is one of the most common neurological disabilities among young people, with a higher incidence in women than in men.

The condition in most patients begins with relapse.-The process of remission, wherein episodes of functional deterioration (relapse) are followed by a recovery period (remission). However, these remissions may be incomplete, leaving patients with residual disabling symptoms. Many (but not all)MSPatients experience persistent disability that progressively worsens over time. In some patients, disability can progress independently of relapses, a process known as secondary progressive multiple sclerosis (SPMS). InSPMSthe initial years, many patients still experience relapses. This phase is referred to as activeSPMS. ActivitySPMSYesMSone of the relapsing forms, and approved for the treatment of relapsing formsMSdrugs can also be used to treat activeSPMS. InSPMSIn the later stages of disease progression, manySPMSThe patient no longer experiences new relapses, but their disability continues to worsen; this phase is referred to as inactive.SPMS。

Mayzent（siponimod) is Novartis (Novartis) developed an oral multiple sclerosis (MS) drug. Its active ingredientsiponimodis a type of targetedS1PNext-Generation Selective Modulators of Specific Receptor SubtypesSiponimodCan bind to lymphocytesS1Preceptor binding, preventing lymphocytes from entering the central nervous system, thereby preventing inflammation. In addition, studies have shown thatsiponimodIt can prevent synaptic degeneration and promote remyelination in the central nervous system.

In aMayzentin the clinical trial, recruited1,651NameSPMSpatients. These patients exhibited continuous progression of disabling symptoms over two years and had no relapses within the three months prior to enrollment. The clinical trial willMayzentComparison with placebo. The primary endpoint of the study was to confirm the progression of disabling symptoms after three months of treatment.MayzentThe proportion of patients with confirmed disability progression in the group was statistically significantly lower than that in the placebo group, whileMayzentIt also reduced the frequency of recurrence in these patients. However, in inactiveSPMSIn the patient subgroups, the results were not statistically significant.

MayzentClear patient medication guides must be provided, including information on drug indications and important risks.MayzentIt may increase the risk of infection; therefore, patients should undergo a complete blood count before initiating treatment. This medication may cause macular edema, so patients should contact their physician promptly if they experience any changes in vision.MayzentMay cause a transient decrease in heart rate and may lead to decreased pulmonary function. Liver enzymes should be checked before initiating drug therapy, and healthcare professionals should closely monitor patients with severe hepatic impairment. Healthcare professionals should monitor patients' blood pressure during treatment. Due to the potential risk of fetal harm, women of childbearing potential should, after discontinuing the medication,10Use effective contraception within days. Healthcare providers should monitor patients for posterior reversible encephalopathy syndrome (PRES) and monitor patients receiving immunotherapy, becauseMayzentMay cause additional immunosuppression.

ParticipationMayzentCommon adverse reactions reported by patients in clinical trials include headache, hypertension, and elevated liver function tests.