FDA raises PML concerns with Takeda's colitis, Crohn's drug vedolizumab
This article was originally published in Scrip
Executive Summary
US FDA drug reviewers on 5 December questioned whether the risks of a rare, serious, progressive neurologic disease, known as progressive multifocal leukoencephalopathy (PML), outweigh the benefits of Takeda's experimental drug vedolizumab in treating moderately to severely active ulcerative colitis (UC) and as a therapy for active Crohn's disease.