Takeda's Inflammatory Bowel Drug's Risks Questioned

Takeda Pharmaceutical Co. (4502)’s drug vedolizumab faces U.S. concern that its potential risk for a deadly brain infection outweighs the benefits in treating the two most common inflammatory bowel diseases. The experimental medicine has the potential to cause a rare virus that attacks the white matter of the brain, Food and Drug Administration staff members wrote in a report today ahead of a Dec. 9 meeting of agency advisers to discuss the therapy. The FDA may decide whether to approve vedolizumab for ulcerative colitis by Feb. 18 and Crohn’s disease in June.

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