FDA approved a new and more efficient drug for patients with multiple sclerosis


The efficacy of Ocrevus for the treatment of relapsing forms of MS was shown in two clinical trials in 1,656 participants treated for 96 weeks.  “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 ocrelizumab drug. Genentech would charge a list price of $65,000 a year, which  is 25 percent less than an existing drug, Rebif, that was shown to be clinically inferior to Ocrevus. The new drug is relatively safe: side effects included reactions at the injection and more upper respiratory infections and cold sores. “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. It’s a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body.


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