FDA approves Mayzent, new oral drug to treat MS

March 27, 2019
The U.S. Food and Drug Administration approved Mayzent® (siponimod) tablets to treat adults with relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The FDA granted approval of Mayzent to Novartis.
 
The efficacy of Mayzent was shown in a clinical trial of 1,651 patients that compared Mayzent to placebo in patients with secondary progressive MS who had evidence of disability progression in the prior two years and no relapses in the three months prior to enrollment. The primary endpoint of the study was the time to three-month confirmed progression in disability. The fraction of patients with confirmed progression of disability was statistically significantly lower in the Mayzent group than in the placebo group. Mayzent also decreased the number of relapses experienced by these patients. In the subgroup of patients with non-active SPMS, the results were not statistically significant.
 
Mayzent must be dispensed with a patient medication guide that describes important information about the drug’s uses and risks. Mayzent may increase the risk of infections, so patients should have a complete blood count taken before treatment is initiated. The drug may cause macular edema, so patients should contact their physician if they experience a change in vision. Mayzent may cause transient decreases in heart rate and may cause a decline in lung function. Liver enzymes should be checked before initiation of the drug and healthcare professionals should closely monitor patients with severe liver impairment. Healthcare professionals should monitor the patient’s blood pressure during treatment. Women of childbearing potential should use effective contraception during and for 10 days after stopping the drug because of the potential risk of fetal harm. Healthcare professionals should monitor patients for posterior reversible encephalopathy syndrome and monitor patients that had treatment with immunosuppressive/immune-modulating therapies because there may be unintended additive immunosuppression with Mayzent.
 
The most common adverse reactions reported by patients receiving Mayzent in the clinical trials include headache, high blood pressure, and liver function test increases.
 
Mayzent is expected to be available in the US in approximately one week. Time of availability may vary as healthcare providers integrate Mayzent into their practices. Patients will not require a first dose observation unless they have certain pre-existing cardiac conditions.
 

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