Ulcerative Colitis

Vedolizumab SC Induces Clinical Remission in Phase 3 Ulcerative Colitis Study

By July 23, 2018

The study included 384 adult patients with moderately to severely active UC who had an inadequate response with, loss of response to, or intolerance to corticosteroids, immunomodulators, or tumor necrosis factor-alpha (TNFα)-antagonist therapy prior to being enrolled.

FDA Approves New Treatment Option for Ulcerative Colitis

By May 30, 2018

The expanded FDA approval was based on results from two 8-week placebo-controlled induction trials and a 52-week maintenance study.

Xeljanz Gets FDA Committee Nod for Ulcerative Colitis Indication

By March 09, 2018

The GIDAC recommendations are provided to the FDA but they are not binding. The FDA has set a target PDUFA action date of June 2018.

Limited Data on Combination Biologic Therapy for IBD, Says Study

By February 28, 2018

The authors point out how, unlike other autoinflammatory conditions, "IBD has the benefit of effective and safe gut specific anti-integrin therapies which can provide a platform off of which combinations can be employed."