USFDA nod to JnJ Tremfya for Crohn's disease
Horsham: Johnson & Johnson has announced that the Company ahs received approval from the U.S. Food and Drug Administration (FDA) for TREMFYA (guselkumab), a IL-23 inhibitor offering both subcutaneous (SC) and intravenous (IV) induction options, for the treatment of adults with moderately to severely active Crohn’s disease (CD), a chronic inflammatory condition of the gastrointestinal tract.
This approval builds upon the FDA approval of TREMFYA in moderately to severely active ulcerative colitis (UC), one of two main forms of inflammatory bowel disease (IBD), which impacts the lives of nearly three million Americans. TREMFYA is a approved fully-human, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including CD.
“Despite the progress in the management of Crohn’s disease, many patients experience debilitating symptoms and are in need of new treatment options,” said Remo Panaccione, MD, FRCPC, Professor of Medicine and the Director of the Inflammatory Bowel Disease Unit at the University of Calgary and lead investigator of the Phase 3 GRAVITI study. “The approval of TREMFYA offers an IL-23 inhibitor that has shown robust rates of endoscopic remission with both subcutaneous and intravenous induction regimens. Importantly, the fully subcutaneous regimen offers choice and flexibility for patients and providers that have not been available before.”
This approval is supported by results from multiple rigorous Phase 3 trials evaluating more than 1,300 patients with moderately to severely active CD who failed or were intolerant to conventional therapy (i.e. corticosteroids or immunomodulators) or biologics. The GRAVITI study evaluated TREMFYA SC induction and maintenance therapy versus placebo. Data from the GALAXI clinical program showed TREMFYA was superior to STELARA in all pooled endoscopic endpoints, the only IL-23 inhibitor to achieve this in a double-blinded registrational program. The comprehensive results from these Phase 3 studies demonstrated the robust efficacy of SC or IV TREMFYA® in achieving clinical and endoscopic endpoints. Highlights from these pivotal studies showed:
| Week 12 Results | GRAVITI | GALAXI 2 | GALAXI 3 | |
| TREMFYA® 400 mg SC induction at Weeks 0, 4 and 8 vs. placebo | TREMFYA® 200 mg IV induction at Weeks 0, 4 and 8 vs. placebo | TREMFYA® 200 mg IV induction at Weeks 0, 4 and 8 vs. placebo | ||
| Clinical remission | 56% vs. 22% (p<0.001) | 47% vs. 20% (p<0.001) | 47% vs. 15% (p<0.001) | |
| Endoscopic response | 34% vs. 15% (p<0.001) | 36% vs. 9% (p<0.001) | 34% vs. 13% (p<0.001) | |
| Week 48 Results | GRAVITI | |||
| TREMFYA® 100 mg SC maintenance q8w starting at Week 16 vs. placebo | TREMFYA® 200 mg SC maintenance q4w starting at Week 12 vs. placebo | |||
| Clinical remission | 59% vs. 17% | 65% vs. 17% | ||
| Endoscopic response | 39% vs. 5% | 48% vs. 5% | ||
| Endoscopic remission | 31% vs. 6% | 40% vs. 6% | ||
| Deep remission (clinical & endoscopic remission)ix | 26% vs. 4% | 34% vs. 4% | ||
“TREMFYA is the first and only IL-23 inhibitor that offers a fully subcutaneous treatment option for moderately to severely active Crohn’s disease. With the approval of TREMFYA, it is now possible to achieve meaningful improvements in clinical and endoscopic outcomes with the flexibility of self-administration from the start,” said Chris Gasink, MD, Vice President, Medical Affairs, Gastroenterology & Autoantibody, Johnson & Johnson Innovative Medicine. “TREMFYA provides people living with Crohn’s disease and their healthcare providers a new treatment option that is supported by data from multiple Phase 3 studies, including pooled analyses showing statistical superiority versus STELARA across four endoscopic or combined clinical and endoscopic endpoints.”
TREMFYA dosing in the treatment of moderately to severely active CD:
- The recommended SC induction dosage is 400 mg (given as two consecutive injections of 200 mg each, dispensed in one Induction Pack) at Weeks 0, 4 and 8. TREMFYA® is also available in a 200 mg prefilled syringe. For the IV induction option, 200 mg IV infusions are administered at Weeks 0, 4 and 8.
- Recommended maintenance dosage is 100 mg administered by SC injection at Week 16, and every 8 weeks thereafter, or 200 mg administered by SC injection at Week 12, and every 4 weeks thereafter. Healthcare providers are instructed to use the lowest effective recommended dosage to maintain therapeutic response.
This approval marks the fourth indication for TREMFYA in the U.S., following moderate-to-severe plaque psoriasis in July 2017, active psoriatic arthritis in July 2020 and moderately to severely active UC in September 2024. In November 2024, Johnson & Johnson submitted a supplemental Biologics License Application (sBLA) to the FDA seeking approval of a SC induction regimen of TREMFYA for the treatment of adults with moderately to severely active UC, based on results of the Phase 3 ASTRO study.
