* Approved for use after other treatments fail
* Marks seventh disease for which Humira has U.S. approval
* Condition affects about 620,000 Americans - NIH
* Abbott shares down nearly 1 percent
Sept 28 U.S health regulators on Friday approved
Abbott Laboratories Inc's blockbuster rheumatoid
arthritis drug Humira for the treatment of moderate to severe
ulcerative colitis, a form of inflammatory bowel disease.
The U.S. Food and Drug Administration approved Humira for
use by adults to help control the chronic condition once
immunosuppressant medicines, such as corticosteroids, have
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 inflammatory diseases. In addition to rheumatoid
arthritis, the medicine is approved for psoriatic arthritis,
ankylosing spondylitis, Crohn's disease, plaque psoriasis and
juvenile idiopathic arthritis.
Morningstar analyst Damien Conover 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 large
intestine, 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," Donna Griebel, of the FDA's Division of
Gastroenterology and Inborn Errors Products, said in a
"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.