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New Drug Approved for Relapsing Forms of Multiple Sclerosis in Adults
The FDA has approved siponimod (Mayzent, Novartis) tablets to treat adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
In some patients with MS, disability progresses independently of relapses, a process known as secondary progressive multiple sclerosis (SPMS). During the first years of SPMS, many patients have continued relapses, a phase described as active SPMS. Active SPMS is a relapsing form of MS, and drugs approved for relapsing forms of MS can be used to treat active SPMS.
Siponimod’s efficacy was demonstrated in a clinical trial comparing siponimod to placebo in 1,651 patients with SPMS who had experienced disability progression in the previous two years and no relapses three months prior to enrollment. The study’s primary endpoint was the time to three-month confirmed progression in disability. The number of patients with confirmed progression of disability was statistically significantly lower in the siponimod group than in the placebo group. Siponimod also reduced the number of relapses experienced by these patients.
As siponimod may increase the risk of infections, patients should have a complete blood count taken before beginning treatment. The drug may cause macular edema, transient decreases in heart rate, and decline in lung function. Women of childbearing potential should use effective contraception during and for 10 days after stopping siponimod because of potential fetal harm.
The most common adverse reactions in patients taking Mayzent in clinical trials were headache, hypertension, and transaminase increase.
Source: FDA, March 26, 2019