FDA approves Humira (Abbott) for patients with moderately to severely active Ulcerative Colitis

The FDA has approved Humira (adalimumab), from Abbott, for inducing and sustaining clinical remission in adult patients with moderately to severely active Ulcerative Colitis (UC) when certain other medicines have not worked well enough. Abbott's submission was supported by results from two Phase III studies, ULTRA 1, an 8-week study, and ULTRA 2, a 52-week study, both of which enrolled adult patients who had moderately to severely active UC despite concurrent or prior treatment with immunosuppressants.

The primary endpoint of both studies was the proportion of patients achieving clinical remission at specified time points (week 8 in ULTRA 1 and weeks 8 and 52 in ULTRA 2), based on subscores of stool frequency, rectal bleeding, physician's global assessment and endoscopy. In the FDA-approved dose, both studies achieved their primary endpoints.

The safety results from both studies were consistent with the known safety profile of Humira and no new safety signals were identified. Combined with its approval to treat moderate to severe Crohn's Disease, the drug is now approved for the treatment of two primary diseases that comprise Inflammatory Bowel Disease (IBD).

Humira was EU approved for this indication in April 2012.