Johnson & Johnson (J&J) Innovation Medicine has submitted a request to the US Food and Drug Administration (FDA) to approve a new way of starting treatment with its drug Tremfya (guselkumab) for adults with ulcerative colitis (UC).
If approved, this option would allow patients to begin treatment with under-the-skin or subcutaneous (SC) injections instead of the intravenous (IV) infusion that is currently required.
The request is based on findings from the Phase III ASTRO study (NCT05528510), which showed that an injection-only induction regimen led to significant symptom relief, known as clinical remission, in 12 weeks. The study also showed improvements in colon healing, with safety results consistent with previous trials.
Tremfya is already approved for UC with an IV induction phase followed by injection-based maintenance therapy, securing FDA approval in September. However, the new filing would offer patients and healthcare providers an alternative approach to starting treatment. Tremfya is also approved for treating plaque psoriasis and psoriatic arthritis, and applications for its use in treating Crohn’s disease are under review in both the US and Europe.
If approved, this would be the first interleukin (IL)-23 inhibitor—a class of drugs targeting a key protein involved in inflammation—to offer a choice of subcutaneous or IV induction in UC. This method could reduce the need for IV infusions, potentially making treatment more accessible and convenient for some patients.
In the announcement accompanying the biologics licence application (sBLA), Esi Lamousé-Smith, vice president and gastroenterology disease area lead in immunology at J&J Innovative Medicine, said: “Tremfya is the first IL-23 inhibitor to potentially offer a fully SC induction and maintenance regimen, which if approved, can provide choice and simplicity for patients and providers.”
J&J’s Tremfya is expected to be the successor to the company’s IL-12/IL-23 inhibitor Stelara (ustekinumab), an approved treatment for severe plaque psoriasis, active psoriatic arthritis, and UC. As per J&J’s annual report, the therapy generated $10.8bn in global sales in 2023, but its future sales are expected to decline with multiple biosimilars entering the market from next year.
Tremfya faces competition from AbbVie’s IL-23 inhibitor Skyrizi (risankizumab), which is approved for the treatment of UC, Crohn’s disease, psoriatic arthritis, and plaque psoriasis. AbbVie also faced losses in sales for its blockbuster immunology drug Humira (adalimumab), when its US patent expired in January 2023 opening up the market to Humira biosimilars and other competitors.
GlobalData projections estimate global sales of $21.97bn for Skyrizi by 2030. Sales for Tremfya in the same year are expected to reach $8.7bn.
GlobalData is the parent company of Pharmaceutical Technology.
