Humira Approved for Ulcerative Colitis Treatment

Sept. 28, 2012 — The FDA has approved Abbott’s Humira for the treatment of moderate to severe ulcerative colitis.

Humira (adalimumab) now is approved for both forms of inflammatory bowel disease (IBD): ulcerative colitis and Crohn’s disease.

It was already approved to treat Crohn’s disease, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, juvenile idiopathic arthritis, and ankylosing spondylitis.

For ulcerative colitis, Humira is approved when other drugs to suppress immune responses haven’t worked.

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