The FDA panel supports the approval of Abbott's adalimumab for the treatment of ulcerative colitis

Source: China Council for the promotion of medicine 2012-08-29 (Reuters) - the U.S Food and drug administration expert group proposed on August 28 that Abbott's heavy explosive ammunition rheumatoid arthritis drug Humira (adamumumab) should be approved to expand its indications for the treatment of ulcerative colitis, an inflammatory intestinal disease FDA's gastrointestinal drug advisory committee, composed of external experts, voted 15:2 to support Humira in the treatment of patients with moderate to severe ulcerative colitis who failed in the standard treatment The FDA panel believes that the benefits of Humira outweigh the risks However, the expert group asked Abbott to conduct more research after approval of Humira (adamumumab) FDA usually considers the panel's recommendations, although it does not have to If approved for ulcerative colitis, Humira will compete with J & J's REMICADE The FDA's approval will also make Humira the first biopharmaceutic drug that can be injected by people themselves to treat ulcerative colitis REMICADE, a competitor, needs intravenous injection Ulcerative colitis is a kind of colitis with colonic ulcer Symptoms include diarrhea, rectal bleeding, incontinence, fever and weight loss In the United States, about 700000 people are said to have the disease The FDA rejected Abbott's application for Humira (adalimumab) for ulcerative colitis last November, asking Abbott to provide further data Abbott completed two clinical trials of Humira for ulcerative colitis involving more than 1000 patients Both tests were positive and improved the remission rate compared with placebo According to the results of the study, the rate of remission in patients treated with Humira (adamumumab) within eight weeks was about 17% - 19%, compared with about 9% in patients treated with placebo A year later, the same results were shown Although some external experts believe that the difference between the remission rate of Humira (adamumumab) and placebo group is meaningless, other experts claim that even a little benefit is helpful for ulcerative colitis with less alternative treatment At present, Humira (adamumumab) has been approved for six indications, including rheumatoid arthritis and Crohn's disease, and the European Union has also approved the indications for ulcerative colitis In 2011, Abbott's Humira sales were about $8 billion Abbott is also studying other indications for the drug, including Crohn's disease in children Link to the original text: http://www.rttnews.com/1955636/fda-panel-backs-expanded-approval-of-abbott-s-humira-to-treat-intensive-sciences.aspx