Main Category: Crohn's / IBD
Also Included In: GastroIntestinal / Gastroenterology;Â Â Regulatory Affairs / Drug Approvals
Article Date: 29 Aug 2012 - 3:00 PDT
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Humira Gets Green Light For Ulcerative Colitis Treatment
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An FDA Advisory Panel has recommended that the US regulatory body authorizes Humira (adalimumab) for the treatment of ulcerative colitis, a type of inflammatory bowel disease. In a 15 to 2 vote in favor of approval, a large majority of the Gastrointestinal Drugs Advisory Committee believe that Humira's benefits outweigh the risks.
Although the FDA (Food and Drug Administration) does not have to abide by the Panel's recommendations, it nearly always does. Abbott Laboratories, the makers and sellers of Humira, say a final decision should be made by the FDA by the end of 2012.
Abbott Laboratories has applied for expanded use of Humira to reduce the signs and symptoms, and also to achieve clinical remission in adults with moderately to severe active ulcerative colitis who had not responded adequately to conventional therapy.
Humira, a TNF inhibitor, mainly known as a rheumatoid arthritis drug, is a blockbuster medication with sales estimated to exceed $9 billion globally this year. It is also approved for psoriatic arthritis, ankylosing spondylitis, Crohn's disease, plaque psoriasis, and juvenile idiopathic arthritis. It is used for pain relief and as an anti-inflammatory in a number of autoimmune diseases.
If Humira can be expanded to treat ulcerative colitis, there would be a sizable market just in the USA. Over 700,000 Americans suffer from ulcerative colitis, and a significant percentage of them have not responded properly to existing treatments. It would also become the first biologic drug that patients could inject themselves, as opposed to Remicade which has to be administered in a hospital.
The Gastrointestinal Drugs Advisory Committee said that Abbott should carry out post-marketing studies if the drug is approved, especially in cases where patients are given high doses.
In November 2011, Abbott's application for expanded use was turned down, the FDA said that clinical trials did not show compelling evidence that Humira stopped the symptoms of ulcerative colitis, including incontinence, pain, fatigue, weight loss, fever, rectal bleeding and diarrhea.
When tested against a placebo, Humira was shown to provide slightly better results. Some wonder whether this difference is meaningful.
Ulcerative colitis, a form of inflammatory bowel disease, is a fairly common chronic disease. It causes inflammation of the large intestine (colon). The colon removes nutrients from undigested food and gets rid of waste products through the rectum. When inflammation is limited to the rectum it can be referred to as ulcerative proctitis. The rectum is always affected in ulcerative colitis.
Conditions which cause inflammation of the intestines are called IBDs (inflammatory bowel diseases). IBD causes inflammation, IBS (irritable bowel syndrome) does not. IBS is a much less serious problem. The terms IBD and IBS are sometimes incorrectly used with the same meaning.
In ulcerative colitis, the colon becomes inflamed; in severe cases there may be painful ulcers in the lining of the colon, which may bleed and produce pus and mucus.
Written by Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
Source: FDA, Medical News Today archives.
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n.p. "Humira Gets Green Light For Ulcerative Colitis Treatment." Medical News Today. MediLexicon, Intl., 29 Aug. 2012. Web.
29 Aug. 2012. <http://www.medicalnewstoday.com/articles/249596.php>
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'Humira Gets Green Light For Ulcerative Colitis Treatment'
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