FDA approves first MS drug for aggressive multiple sclerosis: ocrelizumab (Ocrevus) quoting : CBS News

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Given every six months, it worked best for patients with relapsing multiple sclerosis (MS) — the most common form of the disease, the FDA reported. "The drug offers the first option for patients with primary progressive MS," he added. One involved more than 700 patients with primary progressive multiple sclerosis. "It's a very encouraging result," said Dr. Fred Lublin, director of the Center for Multiple Sclerosis at Mount Sinai Hospital in New York City. Multiple sclerosis is believed to be an autoimmune disease, meaning the body mistakenly attacks itself.



FDA approves first MS drug for aggressive multiple sclerosis: ocrelizumab (Ocrevus)
EspañolOn March 28, the U.S. Food and addiction Administration approved Ocrevus (ocrelizumab) to treat adult patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). This is the first drug approved by the FDA for PPMS. "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. The U.S. Centers for Disease Control and Prevention estimates that approximately 15 percent of patients with MS have PPMS. Ocrevus should not be used in patients with hepatitis B infection or a history of life-threatening infusion-related reactions to Ocrevus.

FDA approves 1st drug for aggressive multiple sclerosis

The Food and addiction Administration approved Ocrevus late Tuesday after a large study found it slowed progression of the neurological disease and reduced symptoms. Compared to study participants getting dummy infusions, patients given Ocrevus infusions had slower declines in walking ability and slower disability progression over nearly 2 1/2 years. TRENTON, N.J. (AP) -- U.S. regulators have approved the first drug for an aggressive kind of multiple sclerosis that steadily reduces coordination and the ability to walk. In those 96-week studies, patients given Ocrevus had lower relapse rates and reduced worsening of disability compared to participants given Rebif, a standard drug for relapsing MS, according to the FDA. In primary progressive MS, the disease's course varies among patients, but symptoms gradually worsen from the start and there usually are no periods when symptoms subside.


collected by :Lucy William

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