U.S. License Holder:
Takeda Pharms. USA
Date of License:
May-20-2014
Last Update:
December-09-2018
FDA-Approved Indications
ENTYVIO (vedolizumab) is an integrin receptor antagonist indicated for:
Adult Ulcerative Colitis (UC): Adult patients with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids: inducing and maintaining clinical response; inducing and maintaining clinical remission improving endoscopic appearance of the mucosa; achieving corticosteroid-free remission;
Adult Crohn's Disease (CD): Adult patients with moderately to severely active CD who have had an inadequate response with, lost response to, or were intolerant to a TNF blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids: achieving clinical response; achieving clinical remission; achieving corticosteroid-free remission.