Takeda colitis drug raises PML concern: FDA staff

December 5, 2013 6:46 PM

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Takeda colitis drug raises PML concern: FDA staff

(Reuters) - An experimental drug for ulcerative colitis and Crohn's disease from Takeda Pharmaceutical Co could pose risk of a potentially fatal brain infection called PML even though the problem has not been seen in clinical trials, staff members of the U.S. Food and Drug Administration said on Thursday.

Documents about the monoclonal antibody, called Entyvio, were released by the FDA staff ahead of a planned meeting on Monday among a panel of outside medical experts who will review the safety and effectiveness of the medicine and make recommendations to the FDA.

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