FDA Approves First Drug for Severe Multiple Sclerosis

Federal officials have approved the first drug to treat people with a severe form of multiple sclerosis (MS), a nervous system disease that harms the brain’s ability to communicate with the rest of the body.

The new drug, called Ocrevus, is sold by the company Genentech and can be given through an intravenous infusion by a health professional.

On Tuesday, the U.S. Food and Drug Administration (FDA) approved Ocrevus to treat primary progressive multiple sclerosis (PPMS) as well as more common relapsing forms of MS. Both diseases are characterized by cognitive decline and weakness. People with MS undergo periods of relapses and remissions, and the cycle can harm mental and physical function. An estimated 15% of people with MS will have PPMS, in which they have steady declines in function usually without relapses or remissions.

In clinical trials, people with MS who took Ocrevus had lower relapse rates and less disability compared to people taking another drug for the disease. In a study of 732 people with PPMS, the drug slowed the men and women’s worsening symptoms better than a placebo. Though the drug does not halt disease progression for people with PPMS, it remains the first and only drug approved the condition.