European Commission (EC) approves Mayzent® (Siponimod) for people with Secondary Progressive MS

The European Commission (EC) approved oral siponimod (brand named Mayzent®, Novartis International AG) for the treatment of adults with active secondary progressive MS (SPMS), with active disease evidenced by relapses or imaging features of inflammatory activity. Approval of Mayzent® provides a new treatment option for people living with secondary progressive MS who are continuing to experience active disease.

This follows the U.S. Food and Drug Administration (FDA) approval of the treatment in March 2019 and the Australian Therapeutic Goods Administration (TGA) in November 2019. 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, Australia and now Europe, 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 in the treatment of progressive MS, this milestone is both important and worthy of celebration.”

Prof. Alan Thompson, Chair of the Alliance’s Scientific Steering Committee, Pro-Vice-Provost (London) and Dean of University College London Faculty of Brain Sciences

About the International Progressive MS Alliance

The Alliance is an unprecedented global collaboration of MS organisations, researchers, health professionals, the pharmaceutical industry, companies, trusts, foundations, donors and people affected by progressive MS, working together to address the unmet needs of people with progressive MS ─ rallying the global community to find solutions.  Our promise is more than hope, it is progress.

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.

Additional Resources

FDA Announcement

Novartis International AG

For further information regarding the International Progressive MS Alliance and its efforts to accelerate breakthrough treatments for people with progressive MS, please contact Graham McReynolds, graham.mcreynolds[at]nmss.org, +1 503-730-1444.

 

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