- TREMFYA® (guselkumab) shows promising Phase 3 study results for ulcerative colitis (UC) with significant clinical and endoscopic improvements at Week 24.
- The drug achieved clinical remission rates of 35.3% and 36.4% in its subcutaneous induction therapy, compared to 9.4% for placebo.
- Johnson & Johnson (JNJ, Financial) submitted an sBLA to the FDA for approval of TREMFYA's subcutaneous induction in UC in November 2024.
Johnson & Johnson (JNJ) has announced encouraging results from the Phase 3 ASTRO study for TREMFYA® (guselkumab) in treating moderately to severely active ulcerative colitis (UC). The study data, derived from a subcutaneous induction therapy regimen, demonstrated significantly improved outcomes at Week 24 across clinical and endoscopic measures compared to placebo.
The clinical remission rates achieved were 35.3% for patients administered 100 mg every eight weeks and 36.4% for those receiving 200 mg every four weeks, in contrast to 9.4% for those given a placebo. Furthermore, the drug exhibited endoscopic improvement in 40.3% and 45.0% of patients respectively, versus 12.2% in the placebo group.
TREMFYA® is poised to become the first and only IL-23 inhibitor offering both subcutaneous and intravenous induction options for UC treatment. The results have shown the drug's efficacy in both biologic/JAK inhibitor-naïve and refractory patient populations, with its safety profile consistent with earlier data.
In line with these findings, Johnson & Johnson submitted a supplemental Biologics License Application (sBLA) to the FDA in November 2024, seeking approval for the subcutaneous induction regimen of TREMFYA® for UC. This strategic move potentially positions TREMFYA® as a significant player in the competitive landscape of inflammatory bowel disease treatments.
