Johnson & Johnson (J&J) is seeking FDA approval for a new subcutaneous (SC) injection formulation of Tremfya (guselkumab) for the treatment of ulcerative colitis (UC) in adults. This new option would allow patients to initiate treatment with SC injections instead of the currently required intravenous (IV) infusion.
The request is based on data from the Phase III ASTRO study (NCT05528510), which evaluated an injection-only induction regimen. The results demonstrated significant symptom relief, achieving clinical remission within 12 weeks. The study also reported improvements in colon healing, with a safety profile consistent with previous Tremfya trials.
Tremfya, an interleukin (IL)-23 inhibitor, is already approved for UC, involving an IV induction phase followed by injection-based maintenance therapy since its FDA approval in September. The new submission aims to provide an alternative treatment initiation method. Tremfya is also approved for plaque psoriasis and psoriatic arthritis, with applications for Crohn’s disease under review in the US and Europe.
Esi Lamousé-Smith, Vice President and Gastroenterology Disease Area Lead at J&J Innovative Medicine, stated, "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."
Current Market and Competition
Ulcerative colitis, characterized by inflammation of the large bowel and rectum, affects a significant portion of the population. Tremfya is positioned as a successor to J&J’s Stelara (ustekinumab), an IL-12/IL-23 inhibitor approved for plaque psoriasis, psoriatic arthritis, and UC, which generated $10.8 billion in global sales in 2023. However, Stelara's sales are anticipated to decline due to biosimilar competition.
Tremfya faces competition from AbbVie’s Skyrizi (risankizumab), another IL-23 inhibitor approved for UC, Crohn’s disease, psoriatic arthritis, and plaque psoriasis. GlobalData projects Skyrizi sales to reach $21.97 billion by 2030, while Tremfya sales are expected to reach $8.7 billion in the same period.
Potential Impact
If approved, the subcutaneous formulation of Tremfya could reduce the need for IV infusions, potentially enhancing treatment accessibility and convenience for patients. This shift could streamline the treatment process and offer a more patient-friendly approach to managing ulcerative colitis.
