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“Multiple sclerosis can have a profound impact on a person’s life,” said Dr. Billy Dunn, director of the agency’s Division of Neurology Products.
MS is an autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. Most people have initial symptoms between the ages of 20 and 40, and MS strikes more women than men, the FDA said in a news release.
Many people with MS are left permanently disabled and worsen over time, the agency said.
Mayzent’s effectiveness was shown in clinical studies of 1,651 people. Progression of disability was significantly lower among those who took Mayzent than in a 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. Since Mayzent may raise the risk of infections, users should have a complete blood count before treatment starts. And users should contact their doctor if they have any vision changes, changes in heart rate or trouble breathing, the FDA said.
Since Mayzent may harm a developing fetus, women of childbearing age should use contraception during treatment and for 10 days after stopping the drug.
The medication is produced by the Swiss drugmaker Novartis.
— Scott Roberts
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