approves for Ulcerative Colitis

Sept 28 (Reuters) – U.S health regulators on Friday approved Inc’s blockbuster rheumatoid arthritis drug Humira for the treatment of moderate to severe ulcerative colitis, a form of .

The U.S. approved Humira for use by adults to help control the chronic condition once immunosuppressant medicines, such as corticosteroids, have proved ineffective.

Humira, by far Abbott’s biggest product with annual sales of about $8 billion and still growing, is already approved to treat a number of . In addition to rheumatoid arthritis, the medicine is approved for psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, plaque psoriasis and .

Morningstar analyst said the latest approval “will help to continue building the franchise” and could eventually add annual revenue approaching $500 million.

Ulcerative colitis, a chronic disease that causes inflammation and ulcers in the inner lining of the , affects about 620,000 Americans, according to the National Institutes of Health.

“Each patient with ulcerative colitis experiences the disease differently, and treatment must be adjusted to meet each individual’s needs,” , of the FDA’s Division of Gastroenterology and Inborn Errors Products, said in a statement.

“Today’s approval provides an important new treatment option for patients who have had an inadequate response to conventional therapy,” she added.

Humira should only continue to be used in patients who have shown evidence of clinical remission after eight weeks of therapy, the FDA said.

Abbott shares were down 65 cents, or nearly 1 percent, at $68.67 on the New York Stock Exchange.


MedPage Today

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About Rob Hill

In 1994, Rob was a fit, healthy 23-year-old, an amateur runner and athlete. Until that time, he had never really been sick. He didn’t even have a regular doctor. When the illness started, it progressed rapidly. Daily diarrhea. Sustained stomach cramps. The diagnosis was Crohn’s disease, an inflammatory condition of the digestive tract. It got worse, and his weight plummeted from 185 to 105 pounds. After a year and a half, it became clear that his large intestine, his colon, needed to be removed. Rob decided he had to do something about it. The Seven Summits campaign, which we call “No Guts Know Glory” grew from Rob’s love of sport, adventure and the outdoors. By taking it to the extreme, and on a global basis, Rob hopes to show people everywhere that having these diseases or having an ostomy, like Rob does, shouldn’t stop you from leading a full life. You may not be able to climb mountains, but there are so many other things you can do. To further this goal, Rob started the Intestinal Disease Education and Awareness Society (IDEAS), from his home base in Vancouver, British Columbia.

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