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

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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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