FDA approves drug for relapsing form of Multiple sclerosis

The FDA has granted approval of Mayzent to Novartis.

MS is a chronic, inflammatory, autoimmune disease of the central nervous system.It is among the most common causes of neurological disability in young adults and occurs more frequently in women than in men.The first symptoms of disease appear in most patients between the ages of 20 and 40.In most people, MS starts with a relapsing-remitting course, in which episodes of worsening function (relapses) are followed by recovery periods (remissions). These remissions may not be complete and may leave patients with some degree of residual disability. Many, but not all, patients with MS experience some degree of persistent disability that gradually worsens over time. In some patients, disability may progress independent of relapses, a process termed secondary progressive multiple sclerosis (SPMS).

“Multiple sclerosis can have a profound impact on a person’s life,” said Billy Dunn, M.D., 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.”

The efficacy of Mayzent was shown in a clinical trial of 1,651 patients that compared Mayzent to placebo in patients with SPMS who had evidence of disability progression in the prior two years and no relapses in the three months prior to enrollment. The primary endpoint of the study was the time to three-month confirmed progression in disability. The fraction of patients with confirmed progression of disability was statistically significantly lower in the Mayzent group than in thel pacebo group. Mayzent also decreased the number of relapses experienced by these patients. In the subgroup of patients with non-active SPMS, the results were not statistically significant.

Mayzent must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. Mayzent may increase the risk of infections, so patients should have a complete blood count taken before treatment is initiated. The drug may cause macular edema, so patients should contact their physician if they experience a change in vision. Mayzent may cause transient decreases in heart rate and may cause a decline in lung function. Liver enzymes should be checked before initiation of the drug and health care professionals should closely monitor patients with severe liver impairment. Health care professionals should monitor the patient’s blood pressure during treatment. Women of childbearing potential should use effective contraception during and for 10 days after stopping the drug due to the potential risk of fetal harm. Health care professionals should monitor patients for posterior reversible encephalopathy syndrome and monitor patients that had treatment with immunosuppressive/immune-modulating therapies because there may be unintended additive immunosuppression with Mayzent.

The most common adverse reactions reported by patients receiving Mayzent in the clinical trials include headache, high blood pressure and liver function test increases.