U.S. FDA approves Mayzent® (Siponimod) for people with secondary progressive MS

The U.S. Food and Drug Administration (FDA) has approved oral siponimod (brand named Mayzent®, Novartis International AG) for the treatment of adults with active secondary progressive MS (SPMS), relapsing forms of MS, and with clinically isolated syndrome (an initial neurological episode). This approval provides a new treatment option for people living with secondary progressive MS who are continuing to experience active disease.

Mayzent® will be available as a first-line treatment, which means that there are no recommendations in the approved labeling for people to try other MS therapies before taking it.

“The approval of a second treatment for progressive forms of MS in the United States marks critical progress in addressing the unmet need of more than one million people living worldwide with progressive MS. While much more must be accomplished, this milestone is both important and worthy of celebration.”

Prof. Alan Thompson, Chair of the Alliance’s Scientific Steering Committee and Dean of University College London Faculty of Brain Sciences

Mayzent® is currently being reviewed by the European Medicines Agency (EMA), the body responsible for drug licensing in Europe. A decision is expected later this year. The U.S. decision was made earlier because the drug was granted priority review status by the FDA, which speeds up the licensing process. The EMA does not have a priority review system.

The Alliance, a global collaboration of MS organizations, researchers, healthcare professionals, the pharmaceutical industry, companies, trusts, foundations, donors and people affected by MS, continues its vital work to accelerate the discovery of new treatments for all people affected by progressive MS.

About Secondary Progressive MS

Secondary Progressive MS (SPMS) follows an initial relapsing-remitting course. Most people who are diagnosed with Relapsing-Remitting MS will eventually transition to a secondary progressive course in which there is a progressive worsening of neurologic function (accumulation of disability) over time. SPMS can be further characterized at different points in time as either active (with relapses and/or evidence of new MRI activity) or not active, as well as with progression (evidence of disease worsening on an objective measure of change over time, with or without relapses) or without progression. Mayzent® is approved for active SPMS.

Further information





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