FDA Approves Siponimod (Brand-named Mayzent®)

The US Food and Drug Administration (FDA) has approved oral Siponimod (brand named Mayzent®, Novartis International AG) to treat clinically isolated syndrome (an initial neurological episode), relapsing forms of MS, and active secondary progressive MS.

Mayzent’s efficacy was studied in a clinical trial of 1,651 patients. The trial compared Mayzent to placebo in patients with secondary progressive MS. Fewer people taking Mayzent had confirmed worsening of disability progression compared to those on placebo. Mayzent also decreased the number of relapses experienced by these patients. Active secondary progressive MS means people who have had progression of disability but still experience acute relapses or new MRI activity. The results of this clinical trial were published in The Lancet in March, 2018.

Mayzent is an oral disease modifying therapy (DMT) taken by mouth daily. It is thought to work by retaining certain white blood cells in the body’s lymph nodes and keeping them out of the central nervous system. It’s designed to be more selective than Gilenya (fingolimod) and potentially have fewer risks. The most common adverse reactions reported during the clinical trial included headache, high blood pressure, and increases in liver function tests. Mayzent may also increase the risk of infections. Click here to read the full prescribing information and Medication Guide.

“The FDA made a very significant statement when approving this drug,” said Dr. Timothy Vollmer, Medical Director of the Rocky Mountain MS Center and Co-Director of the Rocky Mountain MS Center at University of Colorado. “Siponimod was studied in secondary progressive disease, but the FDA is saying it is approved for all forms of active MS. It’s a major shift in the FDA’s view and it’s going to have a major impact on therapeutic development.”

“People should not be limited on their access to these drugs because they have RRMS or SPMS or PPMS,” explained Dr. Vollmer. “The FDA’s position further confirms our understanding that MS is one disease and that it is manifested in different ways because of neurological reserve.”

Knowledge about MS has grown tremendously in the last few decades and this has led to the development of disease modifying therapies. The first DMT was introduced in the 1993, and there are now 17 FDA-approved DMTs in use – adding to our arsenal of treatment tools. We encourage patients to be informed about their condition and all treatment options. Patients should always consult their own physician before commencing any course of treatment.

Additional Resources:

Read the FDA’s press release

Read the full prescribing information and Medication Guide (.pdf)