The U.S. Food and Drug Administration has approved a new oral drug for the treatment of multiple sclerosis (MS)--a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts brain communication. Individuals with MS experience their first symptoms between the ages of 20 and 40. The disease is among the most common causes of neurological disability in young adults and most frequently strikes women more than men.
The approved drug is called Mayzent (siponimod) and comes in the form of tablets prescribed to adults with relapsing forms of multiple sclerosis (MS)—which includes clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
“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.”
MS often begins with a relapsing-remitting course which involves episodes of relapses followed by remissions—which often leave patients with some degree of disability. Although not all patients experience some form of persistent disability, many do and will gradually worsen over time.
The disability in some patients may continue independent of relapses which is known as secondary progressive multiple sclerosis (SPMS). When patients continue to experience relapse during SPMS, this becomes a phase described as active SPMS which is one of the relapsing forms of MS. Although current drugs approved for the treatment of relapsing forms of MS can used to treat symptoms of active SPMS, disability continues to progress--another phase called non-active SPMS.
For Mayzent, the efficacy was confirmed in a clinical trial of 1,651 patients that was compared to a placebo in patients with SPMS who had disability progression in the prior two years with no relapses. Mayzent was found to decrease the progression of disability along with reducing the number of relapses experienced by MS patients. However, in individuals with non-active SPMS, results were found not to be statistically significant.
The FDA granted approval of Mayzent to Novartis.