Johnson & Johnson's Stelara psoriasis drug has shown effectiveness against Crohn's disease in a second late-stage trial, the company said on Friday, bolstering prospects of its approval for the additional use.
The Phase 3 study 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. Those treatments include J&J's own Remicade and AbbVie Inc's Humira.
J&J presented the favorable data on Friday at the 11th Congress of the European Crohn's and Colitis Organization in Amsterdam. In October, the company said Stelara was significantly more effective than placebo in another study of patients with moderate to severe Crohn's symptoms.
Stelara is now awaiting U.S. approval as a treatment for the condition, based on results of that earlier trial.
The drug, which works by blocking two inflammation-causing proteins called IL-12 and IL-23, is one of J&J's biggest, with sales last year of almost $2.5 billion. It is approved in the United States for adults with moderate to severe psoriasis, an inflammatory skin condition caused by an overactive immune system.
Crohn's is a chronic inflammatory condition in the gastrointestinal tract, causing abdominal pain, diarrhea, weight loss and fever. It affects about 700,000 Americans and nearly 250,000 Europeans, J&J said.
Patients in the 741-patient study received either of two intravenous doses of Stelara, or of a placebo. After six weeks, 34 percent of patients receiving either Stelara dose achieved a target reduction in Crohn's symptoms, compared with 22 percent of those taking a placebo.
Similar incidence of side effects and infections were seen in the Stelara and placebo patient groups, J&J said.
Researchers at the meeting said other studies were under way to show whether Stelara can maintain control of Crohn's symptoms over extended periods.
Shares of J&J were up 0.2 percent at $106.92 in morning trading on the New York Stock Exchange.
(Reporting by Ransdell Pierson; Editing by Lisa Von Ahn)
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Published Date: Mar 18, 2016 11:45 pm | Updated Date: Mar 18, 2016 11:45 pm