Although it was adequately assessed in Takeda Pharmaceutical Co. Ltd.’s Entyvio (vedolizumab) development program and no cases were discovered, the risk of progressive multifocal leukoencephalopathy still lingers enough to require a potentially extensive post-marketing risk management plan, an FDA advisory committee concluded.
However, the practitioners at the joint meeting of FDA’s Gastrointestinal Drugs and Drug Safety and Risk Management advisory committees were...