FDA Approves Adalimumab for Ulcerative Colitis

September 28, 2012

September 28, 2012 — The US Food and Drug Administration (FDA) today approved adalimumab (Humira, Abbott Laboratories) for its seventh use: treating ulcerative colitis.

Adalimumab is now indicated for moderate to severe ulcerative colitis in adults who have not been helped by corticosteroids and other immunosuppressant medicines, the FDA stated in a press release today.

A tumor necrosis factor-alpha inhibitor, adalimumab is a blockbuster drug already indicated for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, plaque psoriasis, and juvenile idiopathic arthritis.

Adalimumab is self-injected, in contrast to infliximab (Remicade, Johnson & Johnson), a competing treatment for ulcerative colitis that is given intravenously.

Patients should start with a 160-mg dose of adalimumab, take a second dose of 80 mg 2 weeks later, and then proceed with a maintenance dose of 40 mg every other week, according to the FDA. The drug should be discontinued in patients who have not shown evidence of clinical remission by 8 weeks.

Infections, injection-site reactions, rash, and headache are common adverse reactions.

New Indication Was Turned Down in 2011

The FDA approval of adalimumab for ulcerative colitis did not come easy. The agency turned down Abbott’s application for this indication in November 2011, citing inconclusive evidence of the drug’s ability to stop symptoms such as diarrhea, rectal bleeding, and abdominal pain.

On August 28, however, the FDA Gastrointestinal Drugs Advisory Committee voted overwhelmingly to recommend approval of the drug for ulcerative colitis. It based its decision on 2 clinical trials showing that 16.5% to 18.5% of patients treated with adalimumab experienced clinical remission after 8 weeks compared with 9.2% to 9.3% of patients who received a placebo.

Shortly before the committee vote, FDA staff had questioned whether an efficacy difference of less than 10% between adalimumab and the placebo justified giving the drug to patients in lieu of already approved therapies. Ultimately, the committee decided that the modest benefit was clinically meaningful.

More information about the new indication for adalimumab is available on the FDA Web site.