Entyvio vedolizumab regulatory update

FDA's Gastrointestinal Drugs and Drug Safety and Risk Management advisory committees were unfazed by FDA reviewers' concerns about the potential risk of progressive multifocal leukoencephalopathy (PML) with Entyvio vedolizumab from Takeda's Millennium Pharmaceuticals Inc. subsidiary. The panel members unanimously voted that Takeda adequately characterized the risk of PML with vedolizumab, which is under review to treat ulcerative colitis (UC) and Crohn's disease (CD). The panel also voted 19-1, with 1 abstention, that concomitant immunosuppressants should not be limited to a specific duration of treatment, such as the induction phase.

Of the 21 panel members, 13 voted that the benefits of vedolizumab outweigh the potential risks for UC in patients that have failed steroids, immunosuppressants or anti- TNF alpha therapy, while 8 voted that the benefits outweigh the risks for patients who failed immunosuppressants or anti-TNF alpha therapy but not steroids. For the CD indication, 14 panel members voted that the benefits of vedolizumab outweigh the potential risks for patients who have failed steroids, immunosuppressants or anti-TNF alpha therapy, while 6 voted the benefits outweigh the risks for patients who have failed immunosuppressants or anti-TNF alpha therapy but not steroids. One panel member voted that the benefits did not outweigh the risks for either population of CD patients. ...