Johnson & Johnson (J&J) has submitted a supplemental biologics licence application (sBLA) seeking approval from the US Food and Drug Administration (FDA) for Tremfya (guselkumab) to treat Crohn’s disease. 

This is the company’s second submission for the therapy in inflammatory bowel disease in 2024. It filed an application in March to treat moderately to severely active ulcerative colitis.

The application includes data from the Phase III GALAXI programme, which has shown promising outcomes in head-to-head trials against ustekinumab, and the Phase III GRAVITI study.

Tremfya is a fully human monoclonal antibody and targets IL-23, a cytokine known to be a driver of immune-mediated diseases such as Crohn’s disease.

It has shown potential as the only IL-23 inhibitor providing both subcutaneous and intravenous induction options for Crohn’s disease.

If approved, it could offer flexibility for patient and provider treatment choices.

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Johnson & Johnson innovative medicine immunology global therapeutic area head David Lee stated: “TREMFYA has the potential to be a differentiated treatment option for patients who seek symptom relief and sustained remission.

“We look forward to working with the agency in their review of the data supporting the application as we continue to innovate for people living with inflammatory bowel disease.”

The GALAXI II and III studies demonstrated TREMFYA’s superiority over ustekinumab, meeting co-primary endpoints for subcutaneous maintenance doses.

The Phase III GRAVITI study showed that Tremfya achieved significant clinical remission and endoscopic response at week 12. All controlled endpoints surpassed placebo at weeks 12, 24 and 48.

Encompassing Phase II/III trials, the GALAXI programme assessed the efficacy and safety of guselkumab in patients unresponsive to conventional or biologic therapies.

GALAXI’s design allowed participants to remain on their initial treatment throughout the study, with a long-term extension to evaluate outcomes over five years.

In March 2024, the FDA oncologic drugs advisory committee recommended Johnson & Johnson’s Carvykti (ciltacabtagene autoleucel, cilta-cel) to treat relapsed or refractory multiple myeloma.