Humira is approved to control ulcerative colitis when immunosuppressant medicines like corticosteroids, azathioprine and 6-mercaptopurine have not worked. The drug is an anti-tumor necrosis factor that blocks proteins that play an important role in abnormal inflammatory and immune responses.
FDA previously approved Humira to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, plaque psoriasis and juvenile idiopathic arthritis.
“Each patient with ulcerative colitis experiences the disease differently, and treatment must be adjusted to meet each individual’s needs,” said Donna Griebel, MD, director of the division of gastroenterology and inborn errors products in FDA’s Center for Drug Evaluation and Research, in the release. “Today’s approval provides an important new treatment option for patients who have had an inadequate response to conventional therapy.”
Abbott Laboratories is headquartered in North Chicago, Ill.
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