FDA Advisory Panel Recommends Approval of Humira for Ulcerative Colitis

A Food and Drug Administration advisory panel Aug. 28 voted to recommend approval of Abbott’s Humira (adalimumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.

FDA’s Gastrointestinal Advisory Committee voted 15-2 that the benefits of Humira outweigh its risks for treating UC. The committee also voted 14-2 that additional efficacy studies are not needed prior to approving the drug for this indication.

If approved, Humira would be the only self-administered (by injection) biologic therapy available for UC, according to Abbott’s briefing materials. Humira already is ...