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J&J's Stelara wins expanded US FDA approval for use in bowel disease

Johnson & Johnson said the U.S. Food and Drug Administration approved the expanded use of its drug Stelara for treating certain adult patients with a chronic bowel disease.

The company's pharmaceutical unit Janssen Pharmaceuticals Inc. is developing the drug.

The U.S. regulator approved Stelara, or ustekinumab, for treating adult patients with moderately to severely active ulcerative colitis.

Ulcerative colitis causes long-lasting inflammation and ulcers in the digestive tract and the large intestine. The disease affects about 910,000 people in the U.S., according to an Oct. 21 news release.

The regulator's approval is based on results from a late-stage study, dubbed Unifi. In the study, the drug effectively reduced the symptoms of the disease in patients who had an insufficient or no response to the conventional treatment or were unable to tolerate it.

Stelara is already approved in Europe for treating adult patients with moderately to severely active ulcerative colitis. The drug has also won regulatory approvals for the treating plaque psoriasis, psoriatic arthritis and Crohn's disease.