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

Johnson & Johnson said the European Commission expanded marketing authorization for its drug Stelara to treat certain adult patients with a chronic bowel disease who did not respond to other therapies.

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

The EU regulator approved Stelara, or ustekinumab, for treating adult patients with moderately to severely active ulcerative colitis who had an inadequate or no response to conventional treatment or were intolerant to the therapy. Ulcerative colitis causes long-lasting inflammation and ulcers in the digestive tract and the large intestine.

Stelara's approval for ulcerative colitis is based on results from a phase 3 trial program, called Unifi, where it was shown to be effective in treating the disease.

The European Medicines Agency's Committee for Medicinal Products for Human Use recommended Stelara's approval in July.

Johnson & Johnson submitted a supplemental biologics license application to the U.S. Food and Drug Administration for the approval of Stelara to treat adults with moderately to severely active ulcerative colitis in December 2018.

Stelara secured $2.96 billion in sales for the first six months of 2019, a 23% increase year over year. The drug is already approved for plaque psoriasis, psoriatic arthritis and Crohn's disease.