The U.S. Food and Drug Administration (FDA) has approved siponimod (Mayzent), manufactured by Novartis, for the treatment of multiple sclerosis (MS) in adults.
It is the first oral drug to treat MS, including clinically relapsing-remitting disease, isolated syndrome, and active secondary progressive disease, the FDA announced.
Dr. Billy Dunn, the director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, said, “Multiple sclerosis can have a profound impact on a person’s life. We are committed to continuing to work with companies that are developing additional treatment options for patients with multiple sclerosis.”
FDA approval of Mayzent is based on phase III expand clinical trial. It is expected to hit the American market in approximately a week or two.
According to the FDA’s statement, Siponimod should be dispensed with a patient ‘Medication Guide’ that describes “important information about the drug’s uses and risks.”
Treatment with Mayzent was shown to develop the risk for infections; therefore, patients should have a complete blood count before undergoing treatment with this MS drug. The FDA further added that the drug might cause macular edema, so patients should contact their prescribing doctor if they experience any change in vision.
The statement also notes that the drug may decrease lung function or cause transient bradycardia.
Before initiating the treatment, liver enzymes should be checked. In addition, prescribing doctors should closely monitor patients with severe liver dysfunction and their blood pressure during Siponimod therapy.
The FDA warned that women of childbearing potential must use effective birth control during or for 10 days after stopping Mayzent because of the risk associated with fetal growth.
“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 siponimod,” the agency stated.
