Johnson & Johnson (J&J) is seeking FDA approval for a new subcutaneous (SC) injection-based administration of Tremfya (guselkumab) for the treatment of ulcerative colitis (UC) in adults. This new option would allow patients to initiate treatment with SC injections, offering an alternative to the currently required intravenous (IV) infusion. The application is based on positive results from the Phase III ASTRO study (NCT05528510).
Phase III ASTRO Study Results
The Phase III ASTRO study demonstrated that an injection-only induction regimen of Tremfya led to 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. These findings support the potential of SC Tremfya as an effective and safe induction therapy for UC.
Current Treatment Landscape and Tremfya's Role
Tremfya, an interleukin (IL)-23 inhibitor, is already approved for UC, involving an IV induction phase followed by injection-based maintenance therapy. The new submission aims to provide an alternative treatment initiation approach. If approved, Tremfya would be the first IL-23 inhibitor to offer both SC and IV induction options for UC, potentially improving treatment accessibility and convenience for patients.
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."
Market Context and Competition
Tremfya is positioned as a successor to J&J’s Stelara (ustekinumab), an IL-12/IL-23 inhibitor approved for severe plaque psoriasis, active psoriatic arthritis, and UC. Stelara generated $10.8 billion in global sales in 2023, but faces declining sales due to biosimilar competition. Tremfya also competes with AbbVie’s Skyrizi (risankizumab), an 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.
