Johnson & Johnson's Tremfya Secures FDA Approval for Subcutaneous Use in Ulcerative Colitis, Marking a First for IL-23 Inhibitors

Johnson & Johnson (J&J) has achieved a significant milestone in the treatment of inflammatory bowel disease (IBD) with the recent FDA approval of Tremfya (guselkumab) for subcutaneous induction regimen in adults with moderately to severely active ulcerative colitis (UC). This approval, announced on September 22, 2025, positions Tremfya as the first IL-23 inhibitor to offer both intravenous (IV) and subcutaneous (subQ) dosing options from the start of treatment through maintenance therapy for IBD patients.

Expanding Treatment Options for IBD Patients

The latest FDA nod builds upon Tremfya's initial intravenous approval for UC secured in September 2024 and follows its March 2025 approval for both IV and subQ use in Crohn's disease. This comprehensive set of approvals allows Tremfya to address the needs of nearly 3 million people in the U.S. affected by UC and Crohn's disease, the two primary manifestations of IBD.

Dr. David Rubin, a director at University of Chicago Medicine and investigator on J&J's subcutaneous Tremfya study, highlighted the significance of this development: "Historically, IL-23 inhibitors have required IV infusions at the start of therapy, which can create barriers to starting treatment or be burdensome for some patients and clinicians." The newly approved self-administration format has demonstrated efficacy and safety comparable to the previously approved IV induction dose, potentially simplifying the treatment process for many patients.

Clinical Evidence and Efficacy

The FDA's decision was based on data from J&J's late-stage Astro trial, which employed a treat-through design to assess subcutaneous Tremfya in adult patients who had not benefited from or were intolerant to conventional and advanced UC therapies. Key findings from the trial include:

• An early symptomatic response in UC that diverged from placebo as early as two weeks into the trial, with results sustained through the 24-week mark.
• 26% of patients on the 400 mg dose of injectable Tremfya achieved clinical remission at week 12, compared to 7% on placebo.
• 36% of subcutaneous Tremfya patients demonstrated endoscopic improvement at week 12, versus 12% in the control arm.

These results largely align with those observed in J&J's study of intravenous Tremfya induction therapy in UC, even when accounting for subgroups of patients with severe or refractory disease.

Competitive Landscape and Future Prospects

The approval of subcutaneous Tremfya for UC induction therapy strengthens J&J's position in the competitive IL-23 inhibitor market. Other players in this space include AbbVie's Skyrizi and Eli Lilly's Omvoh, which currently require initial IV infusions for UC treatment.

J&J is not resting on its laurels, announcing the initiation of a head-to-head trial pitting Tremfya against AbbVie's Skyrizi in Crohn's disease. This study could provide J&J with an opportunity to demonstrate Tremfya's superiority, particularly after AbbVie's Skyrizi outperformed J&J's older drug Stelara in a 2023 Crohn's disease head-to-head trial.

Tremfya's expanding indications and dosing options are part of J&J's strategy to position the drug as a successor to Stelara, which now faces biosimilar competition. The company reported strong performance for Tremfya, with sales growing by 31% to $1.2 billion in the second quarter of 2025. Jennifer Taubert, J&J's executive vice president of innovative medicine, noted that Tremfya has already made a "great start" in its launches for both UC and Crohn's disease.

As the pharmaceutical landscape continues to evolve, Tremfya's latest approval marks a significant advancement in IBD treatment options, potentially improving patient convenience and treatment adherence in the years to come.