FDA Approves New MS Treatment

Siponimod (mayzent) has been approved by the US Food and Drug Administration as a new oral treatment for adults with relapsing forms of multiple sclerosis (MS).

After conducting a clinical trial of 1651 patients with secondary progressive MS, the researchers found that siponimod significantly reduced the progression of disability after 3 months of treatment vs placebo. In addition, siponimod reduced the number of disease relapse.

The most common adverse events were headache, hypertension, and liver function test increases.

“Multiple sclerosis can have a profound impact on a person’s life,” said Billy Dunn, MD, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “We are committed to continuing to work with companies that are developing additional treatment options for patients with multiple sclerosis.”

—Amanda Balbi

Reference:

FDA approves new oral drug to treat multiple sclerosis [press release]. Silver Spring, MD: US Food and Drug Administration; March 26, 2019. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634469.htm. Accessed March 27, 2019.