Abbott's HUMIRA® (adalimumab) met its primary endpoint of clinical remission in a Phase III study of adult patients with moderate to severe ulcerative colitis (UC). Ulcerative colitis (UC) is a chronic autoimmune disease that causes inflammation and ulceration in the lining of the colon or large intestine. It is estimated that approximately 700,000 people in the United States have UC.
"People living with ulcerative colitis currently have very few treatment options to help them manage their disease," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott. "We are encouraged by these study results with HUMIRA and the potential they may have for patients."
HUMIRA is not currently approved for the treatment of UC. Abbott recently submitted applications to both the U.S. Food and Drug Administration and the European Medicines Agency seeking approval to market HUMIRA for the treatment of moderate to severe UC. Currently, HUMIRA is approved to treat conditions like rheumatoid arthritis and ankylosing spondylitis -- and it is one of the lead selling biologics in the world.
Posted by Bruce Lehr May 21st 2011.