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(Reuters) – Johnson & Johnson said Tuesday that its star drug, Stelara, was effective in treating chronic intestinal disease as part of a final-phase clinical trial.
Two doses of Stelara, previously approved for psoriasis, psoriatic arthritis and Crohn's disease, were tested in 961 patients with moderate to severe ulcerative colitis without previous treatment.
Intravenous treatment at 6 mg / kg and 130 mg / kg showed clinical remission in significantly more patients compared to placebo after eight weeks, the company said.
Treatment and placebo groups reported a similar proportion of side effects, a patient taking the dose of 6 mg / kg dying as a result of excessive bleeding, said J & J.
The patient had no history of high blood pressure or cirrhosis, said the drug's manufacturer.
"More than half of patients with UC have not experienced remission with currently available treatment options," said study lead researcher, Bruce Sands.
Stelara, which generated a business turnover of $ 1.34 billion in the second quarter of 2018, is also tested in lupus, an autoimmune disease.
Ulcerative colitis, which affects approximately 38,000 people each year in the United States, is a chronic condition leading to abdominal pain, intestinal ulcers, bloody diarrhea, and weight loss.
Current treatments include Xelijanz from Pfizer Inc, an oral therapy for adult patients with moderate to severe UC, and Renflexis from Merck & Co.
(Report by Manogna Maddipatla in Bengaluru, edited by Sriraj Kalluvila)
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