- Johnson & Johnson's top-selling drug Stelara appears well-positioned to continue the sales growth that made it a blockbuster, as new data from a pivotal trial released Tuesday showed the drug to be effective in treating ulcerative colitis (UC).
- Treatment with the IL-12 and IL-23 antagonist led to higher clinical response and remission rates than placebo after eight weeks in patients with moderate to severe UC who previously had inadequate responses or were intolerant to conventional or biologic therapies.
- Stelara was previously approved for psoriasis, psoriatic arthritis and Crohn's disease. J&J anticipates filing a Biologics License Application for UC by the end of 2018 with the Food and Drug Administration and also applying in Canada, Europe and Japan in early 2019.
Stelara (ustekinumab) became Johnson & Johnson's best-selling drug earlier this year, and new indications will be crucial to continue the steady sales gains the biologic has enjoyed over the past few years.
Last year, the blockbuster exceeded $4 billion in worldwide sales and has netted $2.4 billion through the first half of 2018.
After winning FDA approval for Crohn's disease in September 2016, sales for that indication alone are growing at a pace to exceed $1 billion for 2018, according to company estimates from last month.
Securing a UC indication would allow Stelara to further expand its presence in the inflammatory bowel disease space. Topline data from a Phase 3 trial called UNIFI makes that aim a surer prospect.
Researchers evaluated 961 patients after eight weeks of treatment, who were randomly given either a fixed dose of Stelara, an amount based on the patient's weight or placebo. Stelara achieved statistical significance in its primary goal of achieving clinical remissions and the secondary endpoints of clinical responses, endoscopic healing and mean change from an inflammatory bowel disease questionnaire score.
Roughly three times as many patients achieved clinical remission than compared to placebo. Slightly more than a quarter of those treated with Stelara had endoscopic healing, and 51% on the fixed dose and 62% on the weight-dependent dose registered a clinical response compared to 31% on placebo.
"These induction data from the Phase 3 UNIFI study underscore the potential for this pathway in the treatment of UC, which may lead to a new effective and safe treatment option for UC patients in the future," Philippe Szapary, vice president of clinical development for J&J's pharmaceutical subsidiary Janssen, said in an Oct. 9 statement.
The UNIFI trial will continue, with an expected completion date in November 2021. Patients that achieved a clinical response will be eligible to participate in a maintenance study that will test them after 44 weeks of treatment. After that study finishes, eligible patients will also be followed by an extension study for three more years, according to a release from Janssen.
The eight-week data will be presented Tuesday afternoon at the American College of Gastroenterology's annual scientific meeting.