Johnson & Johnson seeks FDA nod for Tremfya in Crohn's disease

Johnson & Johnson (J&J) has progressed with a significant step by submitting a supplemental biologics license application (sBLA) to the US Food and Drug Administration (FDA) for the approval of Tremfya (guselkumab) targeting Crohn’s disease. This submission marks the company’s second attempt in 2024 to seek approval for the drug in the field of inflammatory bowel disease, following a previous application in March to address moderately to severely active ulcerative colitis.

The application is fortified with data derived from the extensive Phase III GALAXI programme, which has demonstrated promising results in comparative trials against ustekinumab, and the Phase III GRAVITI study. Tremfya, a fully human monoclonal antibody, focuses on inhibiting IL-23, a cytokine implicated in immune-mediated diseases like Crohn’s disease. Notably, it stands out as the sole IL-23 inhibitor that offers both subcutaneous and intravenous induction options for treating Crohn’s disease.

David Lee, the global therapeutic area head of innovative medicine immunology at Johnson & Johnson, emphasized the potential impact of Tremfya. He remarked, “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.” If Tremfya gains approval, it could provide greater flexibility in treatment choices for both patients and healthcare providers.

The GALAXI II and III studies have underscored TREMFYA’s superiority over ustekinumab, achieving co-primary endpoints for subcutaneous maintenance doses. The Phase III GRAVITI study further revealed that Tremfya significantly achieved clinical remission and endoscopic response by week 12, with all controlled endpoints outperforming placebo treatments at weeks 12, 24, and 48.

The GALAXI programme, encompassing Phase II/III trials, was designed to evaluate the efficacy and safety of guselkumab in patients who had not responded adequately to conventional or biologic therapies. This programme's structure allowed participants to continue their initial treatment throughout the study, with a long-term extension to monitor outcomes over five years, providing a robust data set to support the application.

In addition to its endeavors with Tremfya, Johnson & Johnson has been active in other therapeutic areas. In March 2024, the FDA oncologic drugs advisory committee recommended Carvykti (ciltacabtagene autoleucel, cilta-cel) for the treatment of relapsed or refractory multiple myeloma.

The data from these comprehensive studies highlight the potential of Tremfya as a groundbreaking treatment for Crohn’s disease. As J&J continues its efforts to gain FDA approval, the possibility of Tremfya becoming a versatile and effective treatment option for patients with inflammatory bowel diseases grows more tangible. The ongoing commitment of Johnson & Johnson to innovate and improve treatment options for individuals with these chronic conditions is evident in their continued research and application efforts.