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You are here: Home / Articles / FDA Approves Ustekinumab for Crohn’s Disease

FDA Approves Ustekinumab for Crohn’s Disease

September 26, 2016 • By Reuters Staff

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

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

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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 ustekinumab 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.

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

Johnson & Johnson’s shares were about 1% lower at $117.83 in morning trading.

Filed Under: Biologics & Biosimilars, Drug Updates Tagged With: Crohn's disease, FDA, Food and Drug Administration, inflammatory bowel disease, ustekinumab

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