News from the FDA/CDC

FDA approves siponimod for relapsing forms of MS


The Food and Drug Administration has approved siponimod (Mayzent) tablets for the treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS.

FDA icon Wikimedia Commons/FitzColinGerald/Creative Commons License

Siponimod is a selective sphingosine 1-phosphate (S1P) receptor modulator that binds to S1P1 and S1P5 receptors. Its binding to the S1P1 receptor prevents lymphocytes from leaving the lymph nodes, which contributes to the treatment’s anti-inflammatory effects. Its binding to the S1P5 and S1P1 subreceptors on oligodendrocytes and astrocytes is intended to promote remyelination and prevent inflammation.

The treatment’s approval is based on the results of the phase 3 EXPAND study, according to the agency’s March 26 announcement. This randomized, double-blind study compared siponimod with placebo among 1,651 patients with secondary progressive MS. At baseline, the population’s mean age was 48 years, and mean disease duration was approximately 16 years. More than half the study population had a median Expanded Disability Status Scale score of 6.0 and relied on a walking aid.

Siponimod reduced the risk of 3-month confirmed disability progression (CDP) by 21%, compared with placebo (P = .013). Among participants with relapse activity in the 2 years prior to screening, siponimod reduced the risk of this outcome by 33%, compared with placebo (P = .0100). Siponimod delayed the risk of 6-month CDP by 26%, compared with placebo (P = .0058) and reduced the annualized relapse rate by 55%. In addition, the data suggested beneficial effects of siponimod on cognition, MRI disease activity, and brain volume loss. Siponimod did not provide significant improvements in patients with nonactive secondary progressive MS.

Common adverse events included headache, hypertension, and transaminase increase. The FDA requires siponimod to be dispensed with a medication guide that describes the treatment’s associated risks of infection, macular edema, decreased heart rate, and impaired lung function.

Novartis manufactures the drug. The company expects the drug to be available within 1 week, according to its press release.

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