WEDNESDAY, March 27, 2019 -- Mayzent (siponimod) pills have been approved by the U.S. Food and Drug Administration for adults with relapsing multiple sclerosis (MS).
"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.
Mayzent's most common side effects include headache, high blood pressure and liver problems.
The medication is produced by the Swiss drugmaker Novartis.
Visit the FDA to learn more.
Mayzent Approved for Relapsing MS large Shift in How Centers Perform CTO PCI - m MedNews
Dive Insight: For many MS patients, the disease is in a Mobile Device World, Toddlers Still Watching Too Much TV defined by acute relapses or attacks, between which their symptoms lessen or remain stable. The risk of disability progression at six months was of 26 compared to placebo. Gilenya, which last year earned Novartis.3 billion, costs 98,500 per year while Biogen's Tecfidera is priced at 93,700. According to the FDA's observation, Siponimod should be disbursed with a affected person 'Medication Guide' that describes "vital guidance about the drug's makes use of and risks.". Treatment for...
FDA approval of Mayzent is based on part III extend clinical trial. "We are confident we have appropriately priced Mayzent to enable affordable access for people with MS Novartis said in an emailed statement. Novartis has a patent on the dosage regimen for the drug that runs through 2027, however potentially enough to keep generic rivals at bay. Mayzent may increase the risk of infections, and its accompanying medication guide makes recommendations to possible serious side effects, including that patients undergo a complete blood count prior to starting this therapy.