The Food and Drug Administration approved on Tuesday the first drug to treat a severe form of multiple sclerosis, offering hope to patients who previously had no other options to combat a relentless disease that leads to paralysis and cognitive decline.
The federal agency also cleared the drug to treat people with the more common, relapsing form of the disease.
“I think that this is a very big deal,” said Dr. Stephen Hauser, the chairman of the neurology department at the University of California, San Francisco, and leader of the steering committee that oversaw the late-stage clinical trials of the drug, ocrelizumab. “The magnitude of the benefits that we’ve seen with ocrelizumab in all forms of M.S. are really quite stunning.”
The drug, which will be sold under the brand name Ocrevus by Genentech, showed the most notable results in patients with relapsing multiple sclerosis, appearing to halt progression of the disease with few serious side effects. In patients with the more severe form, primary progressive multiple sclerosis, the drug only modestly slowed patients’ decline, but medical experts described it as an important first step.