FDA OKs Humira for ulcerative colitis

The FDA today approved Humira as a treatment for moderate-to-severe ulcerative colitis in adult patients, according to a press release.

The anti-TNF (adalimumab, Abbott Laboratories) is intended for use in patients who have not responded to previous immunosuppressant therapy. Approved dosage includes an initial, subcutaneous 160-mg dose followed by an 80-mg injection after 2 weeks, and subsequent biweekly maintenance doses of 40 mg. Treatment should be discontinued after 8 weeks if patients do not exhibit signs of clinical remission.

Other approved indications for Humira include Crohn’s disease; rheumatoid, psoriatic and juvenile idiopathic arthritis; plaque psoriasis and ankylosing spondylitis. Commonly reported side effects include infection, headache, rash and reactions at the injection site, according to the release.

The approval follows results from two clinical trials outlining Humira’s safety and efficacy. At an FDA advisory committee meeting conducted in August, the majority of members voted that study results for Humira indicated a clinically meaningful benefit that outweighed potential risks, but dosage had not been sufficiently established as optimal.

“Each patient with ulcerative colitis experiences the disease differently, and treatment must be adjusted to meet each individual’s needs,” Donna Griebel, MD, director of the FDA’s gastroenterology and inborn errors products division, Center for Drug Evaluation and Research, said in the release. “Today’s approval provides an important new treatment option for patients who have had an inadequate response to conventional therapy.”