CORRECTED-FDA approves J&J's autoimmune drug Stelara for Crohn's disease

Last Updated: 2016-10-07

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By Reuters Staff

(Reuters) - Johnson & Johnson said on Monday that the U.S. Food and Drug Administration approved the company's blockbuster psoriasis drug, Stelara (ustekinumab), for use in adults with Crohn's disease.

The drug is approved in the United States to treat plaque psoriasis and a type of arthritis associated with psoriasis.

Crohn's is a chronic inflammatory condition in the gastrointestinal tract, causing abdominal pain, diarrhea, rectal bleeding, weight loss and fever. It affects about 700,000 Americans and nearly 250,000 Europeans, according to the company.

Late-stage trial data showed Stelara induced remissions in moderate-to-severe Crohn's disease patients who had previously failed to benefit from TNF inhibitors, a leading class of medicines for the inflammatory bowel disease.

The drug, which blocks two inflammation-causing proteins IL-12 and IL-23, is one of J&J's largest revenue generators, with sales of about $2.5 billion in 2015.

J&J's shares were about a percent lower at $117.83 in morning trading.