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FDA Approves Mayzent for Relapsing Multiple Sclerosis

WEDNESDAY, March 27, 2019 -- Mayzent (siponimod) pills have been approved by the U.S. Food and Drug Administration for adults with relapsing multiple sclerosis.

Mayzent's effectiveness was shown in clinical studies of 1,651 patients. Progression of disability was significantly lower among those who took Mayzent than in the group that took a placebo. Mayzent also decreased the number of relapses, the FDA said.

The drug must be accompanied by a patient medication guide that describes the medication's uses and risks. Because Mayzent may raise the risk for infections, users should have a complete blood count before treatment starts. Users should also contact their doctor if they have any vision changes, changes in heart rate, or trouble breathing, the FDA said. Because Mayzent may harm a developing fetus, women of childbearing age should use contraception during treatment and for 10 days after stopping the drug. Mayzent's most common side effects include headache, high blood pressure, and liver problems.

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

The medication is produced by the Swiss drug maker Novartis.

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Posted: March 2019

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