J&J seeks FDA nod for Tremfya injection in ulcerative colitis

Johnson & Johnson (J&J) has submitted a request to the US Food and Drug Administration (FDA) for the approval of a new administration method for its drug Tremfya (guselkumab) aimed at treating adults with ulcerative colitis (UC). The new method would enable patients to start treatment with subcutaneous (SC) injections instead of the intravenous (IV) infusions currently required.

This submission is based on results from the Phase III ASTRO study (NCT05528510), which demonstrated that an induction regimen relying solely on injections led to significant symptom relief, or clinical remission, within 12 weeks. It also showed improvements in colon healing, with safety outcomes in line with previous trials. Tremfya is already approved for UC with an initial IV phase followed by injection-based maintenance therapy, having secured FDA approval in September. This new filing could provide an alternative treatment initiation approach for patients and healthcare providers.

Tremfya is also approved for treating plaque psoriasis and psoriatic arthritis, and applications for its use in Crohn’s disease are under review in both the US and Europe. Should the new administration method be approved, Tremfya would become the first interleukin (IL)-23 inhibitor, a class of drugs targeting a protein involved in inflammation, to offer a choice between subcutaneous or IV induction for UC. This change could potentially reduce the need for IV infusions, making treatment more accessible and convenient for some patients.

Esi Lamousé-Smith, vice president and gastroenterology disease area lead in immunology at J&J Innovative Medicine, highlighted the potential benefits of the fully SC induction and maintenance regimen. She emphasized that, if approved, this could provide patients and providers with more choices and simplicity in managing the condition.

Tremfya is anticipated to be the successor to J&J’s IL-12/IL-23 inhibitor Stelara (ustekinumab), which is currently approved for severe plaque psoriasis, active psoriatic arthritis, and UC. According to J&J’s annual report, Stelara generated $10.8 billion in global sales in 2023. However, its future sales are projected to decline due to the entry of multiple biosimilars into the market starting next year.

Additionally, Tremfya faces competition from AbbVie’s IL-23 inhibitor Skyrizi (risankizumab), which is approved for treating UC, Crohn’s disease, psoriatic arthritis, and plaque psoriasis. AbbVie experienced a drop in sales for its immunology drug Humira (adalimumab) when its US patent expired in January 2023, opening the market to Humira biosimilars and other competitors.

Projections from GlobalData estimate that Skyrizi will achieve global sales of $21.97 billion by 2030, while Tremfya's sales are expected to reach $8.7 billion in the same year.

These developments illustrate the competitive and evolving landscape of therapies for inflammatory conditions like ulcerative colitis, with potential new options on the horizon that could enhance patient experience and treatment efficacy.