On Tuesday, the U.S. Food and Drug Administration approved oral drug Mayzent as a treatment option for adults with variants of multiple sclerosis (MS).
“Multiple sclerosis can have a profound impact on a person’s life,” said Dr. Billy Dunn, head 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 approval comes as the first FDA-approved treatment for secondary progressive MS in more than a decade. The chronic, inflammatory, autoimmune disease affects more than 2.3 million people worldwide and occurs more frequently in women than in men. Most patients experience bouts of relapses followed by recovery, or remission, periods. Many with MS experience a persistent, worsening disability over time—a process known as secondary progressive multiple sclerosis (SPMS). A clinical trial of 1,651 showed that Mayzent was effective in helping treat SPMS compared to a placebo.
“Mayzent also decreased the number of relapses experienced by these patients,” the FDA press release stated.
The FDA has granted approval of the drug to Swiss pharmaceutical company Novartis, which has priced the treatment at $88,500 a year. An analysis by the Institute for Clinical and Economic Review found that the drug could be priced at almost 87% less and still be cost-effective for the firm.