Janssen has submitted a supplemental Biologics License Application (sBLA) seeking approval of Stelara (ustekinumab) for the treatment of moderate-to-severely active ulcerative colitis (UC).
Stelara, a human interleukin-12 and interleukin-23 antagonist, is already approved to treat moderate-to-severe plaque psoriasis, active psoriatic arthritis and moderate-to-severe Crohn’s disease.
The sBLA is supported by data from the UNIFI global clinical development program. In the Phase 3 induction study, 961 UC patients were randomized to receive a single dose of either placebo, Stelara 130mg, or Stelara ~6mg/kg (based on weight). At week 8, 15.6% of patients receiving Stelara 130mg and 15.5% of patients receiving Stelara ~6mg/kg achieved clinical remission compared with 5.3% of patients receiving placebo (P<.001). Data from the Phase 3 maintenance trial will be released some time next year.
“We’re excited to bring this innovative therapy, with a proven track record in Crohn’s and other immune diseases, one step closer to being available for people living with ulcerative colitis,” said Scott E. Plevy, MD, Gastroenterology Disease Area and IL-23 Pathway Leader, Janssen Research & Development, LLC.
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