The decision includes clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
The move follows a clinical trial in which the proportion of patients with confirmed progression of disability was statistically significantly lower in the Mayzent group than in the placebo group.
“Multiple sclerosis can have a profound impact on a person’s life,” said Billy Dunn, 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 Swiss drugmaker will price the treatment at $88,000 per year, its head of pharmaceuticals Paul Hudson told Reuters.
For most people, MS starts with a relapsing-remitting course, in which episodes of relapsed 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.
