- Johnson & Johnson's Stelara (ustekinumab) is currently indicated for treatment of psoriasis and psoriatic arthritis, and now J&J is planning to file the drug for moderate-to-severe Crohn's in global markets.
- Crohn's disease is a form of inflammatory bowel disease (IBD), which affects roughly 700,000 Americans.
- Stelara sales in Q3 2015 were $613 million.
Although Stelara is facing real competition from a slew of contenders including Novartis' Cosentyx and Valeant's brodalumab, J&J had positive phase 3 data to report for use of Stelara in patients with moderate-to-severe Crohn's disease, who were not able to control their disease with other therapies.
In the six-week study, which included 628 patients, patients received one of two doses of Stelara or placebo. In terms of results, 52% and 56% of the patients in the two Stelara treatment groups, versus 29% of placebo-treated patients, experienced clinical response of at least 100 points reduction from baseline in activity in the Crohn's Disease Activity Index.
J&J will be filing in the U.S. and other global regulatory markets before the end of the year.