The Gastrointestinal Drugs and Drug Safety and Risk Management advisory committees met to review concerns that the biologic carries risk of progressive multifocal leukoencephalopathy.
The manufacturer, Takeda Pharmaceuticals, has filed applications with the FDA for vedolizumab as a treatment for moderate to severely active ulcerative colitis and moderate to severely active Crohn’s disease.
The joint advisory committee will vote on whether or not to recommend approval for both indications of the biologic.
View the briefing document.
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