Johnson & Johnson (J&J) is seeking the US Food and Drug Administration (FDA) approval for Tremfya (guselkumab) to treat moderately to severely active Crohn’s disease.
The US-based pharmaceutical company has submitted a supplemental Biologics License Application (sBLA) to the FDA, for the Tremfya.
It is the second submission to the FDA for Tremfya in inflammatory bowel disease (IBD) this year, following an application for moderately to severely active ulcerative colitis in March.
The latest sBLA submission is based on results from the Phase 3 GALAXI program, which includes GALAXI 2 and GALAXI 3 studies.
In the studies, Tremfya met the co-primary endpoints for both SC maintenance doses (200mg every 4 weeks and 100mg every 8 weeks) compared to placebo.
Also, the drug showed superiority to ustekinumab in multiplicity-controlled endoscopic endpoints based on data pooled from both studies.
J&J’s sBLA submission is also based on results from the Phase 3 GRAVITI investigational study that evaluated Tremfya SC induction therapy in moderately to severely active Crohn’s disease.
The Phase 3 study met the co-primary endpoints of statistically significant and clinically meaningful outcomes for clinical remission and endoscopic response, at Week 12.
The study also met all the multiplicity-controlled endpoints, compared to placebo at Week 12, Week 24 and Week 48.
Results from GALAXI and GRAVITI show that Tremfya has the potential to become the only IL-23 inhibitor to offer both subcutaneous or intravenous induction options for Crohn’s disease.
Johnson & Johnson innovative medicine global immunology therapeutic area head David Lee said: “Building upon nearly three decades of leadership and innovation in immunology, we are committed to addressing the needs of people living with Crohn’s disease through deep, scientific expertise and through our continued pioneering advances in the IL-23 pathway.
“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.”
