Inflammatory Bowel Disease

Discussing the latest advances in Crohn’s disease and ulcerative colitis

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February 11, 2014

Vedolizumab Being Reviewed by the FDA

By Margaret Shepard, Communications Specialist

Ed Loftus, M.D., discusses recent developments on a drug, vedolizumab, that is currently being reviewed by the Food and Drug Administration for inflammatory bowel disease. Vedolizumab is thought to be more gut specific and potentially have fewer adverse side effects.

In December, an advisory committee convened by the FDA met to review all the data and recommend whether vedolizumab should be used to treat ulcerative colitis and Crohn's disease. The committee was reviewing if the drug would cause progressive multifocal leukoencephalopathy (PML), a serious neurological condition. Since the drug is gut specific, it doesn't appear to affect the blood brain barrier. Over 3,000 patients have been treated with this drug and there have not been any cases of PML.

In the end, the committee did recommend the drug be approved to treat Crohn's disease and ulcerative colitis. It is up to the FDA to approve the drug for treatment. The date of approval by the FDA is late May for ulcerative colitis and June for Crohn's disease.

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Dr. Loftus is a clinical gastroenterologist at the Mayo Clinic specializing in the care of patients with Crohn's disease and ulcerative colitis.

Tags: Edward Loftus, FDA, Study Findings, Vedolizumab

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