Mayzent (Siponimod) Granted FDA Approval for SPMS

March 27, 2019

The next-generation oral drug is the first to be approved specifically for secondary progressive multiple sclerosis in more than 15 years.

Novartis’ Mayzent (siponimod) has gained FDA approval, making it the first treatment to be approved to treat secondary progressive multiple sclerosis (SPMS) in 15 years. 

Siponimod is a next-generation selective sphingosine-1-phosphate receptor modulator and is indicated for the treatment of adults suffering from various relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease. 

The drug acts by binding to S1P1 and S1P5 receptors and prevents lymphocytes from leaving the lymph nodes and entering the central nervous system. 

During clinical trials, the most common side effects reported were headache, high blood pressure, and liver function test increases. The FDA warns that the drug may also cause an increased risk of infection, macular edema, transient decreases in heart rate, and decline in lung function.

Health care professionals should monitor patients for the development of posterior reversible encephalopathy syndrome and potential unintended additive immunosuppression in patients previously treated with immunosuppressive or immune-modulating therapies.  

"One of the most important aims of MS treatment is delaying disability progression and preserving cognition," says Paul Hudson, chief executive officer for Novartis Pharmaceuticals. "With Mayzent, SPMS patients with active disease will have access to the first effective oral therapy directed towards disease progression, even when MS transitions to a stage where deterioration is less dependent on the usual relapse activity.

Novartis says Mayzent will be available in about a week.

Continue to page 2 for prescribing information

Prescribing Information 

Indications: treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults

Dosage: 0.25 mg and 2 mg tablets 

Contraindications: 

  • patients with a CYP2C9*3/*3 genotype

  • patients that have experienced myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization, or Class III/IV heart failure within the last 6 months

  • presence of Mobitz type II second-degree, third-degree AV block, or sick sinus syndrome, unless patient has a functioning pacemaker

Full Prescribing Information