Expert panel recommends FDA approve Takeda bowel disease drug

Mon Dec 9, 2013 5:44pm EST

Dec 9 (Reuters) - An advisory panel of medical experts on Monday voted to recommend that U.S. health regulators approve an experimental drug for ulcerative colitis and Crohn's disease developed by Takeda Pharmaceutical Co.

There were specific safety and efficacy questions for each of the two conditions put before the panel. It ultimately found by wide margins that the benefits outweigh the risks of the biotech drug, vedolizumab, and advised the Food and Drug Administration to approve it for ulcerative colitis and Crohn's disease in patients who have not been helped by prior therapies.

The FDA typically follows the recommendations of its expert advisory panels but is not obligated to do so.

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