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FDA panel questions whether bowel disease drug increases risk of deadly brain infection

A Food and Drug Administration (FDA) advisory panel is questioning the safety of Takeda Pharmaceutical’s inflammatory bowel disease drug candidate vedolizumab, claiming the drug could cause patients to develop a rare but deadly brain infection. The panel is set to rule on Dec. 9 whether to recommend the drug be approved for marketing in the United States. The medication fared well in clinical trials as a treatment for ulcerative colitis and Crohn’s disease, but experts say the drug carries the risk of progressive multifocal leukoencephalopathy (PML), a life threatening brain disease that affects immune deficient patients. No patients in clinical ... Read More