Johnson & Johnson seeks FDA approval for TREMFYA® to treat Crohn's disease

Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval for the use of TREMFYA® (guselkumab) in adults with moderate to severe Crohn's disease. This application is backed by promising 48-week results from Phase 3 clinical trials, including the GALAXI and GRAVITI programs. If approved, TREMFYA® could become the first IL-23 inhibitor offering both subcutaneous (SC) and intravenous (IV) induction therapy options for this demographic.

TREMFYA®'s efficacy in treating Crohn's disease is underscored by data from the GALAXI program, which was highlighted at Digestive Disease Week (DDW) 2024. These studies, GALAXI 2 and GALAXI 3, were the first double-blind, head-to-head trials showcasing TREMFYA®'s superiority over STELARA® (ustekinumab). Both studies met their primary endpoints for SC maintenance doses (200 mg every four weeks and 100 mg every eight weeks) compared to placebo. They also demonstrated superior endoscopic results when compared to ustekinumab.

The submission dossier also includes findings from the Phase 3 GRAVITI study, which evaluated TREMFYA®'s SC induction therapy in adults with moderate to severe Crohn's disease. The GRAVITI study met its co-primary endpoints of clinical remission and endoscopic response at Week 12. Additionally, all multiplicity-controlled endpoints were met at Weeks 12, 24, and 48, indicating sustained efficacy.

David Lee, M.D., Ph.D., Global Therapeutic Area Head Immunology at Johnson & Johnson, remarked on the significance of these findings. He stated that TREMFYA® could offer a new treatment option for patients seeking symptom relief and sustained remission. The company looks forward to collaborating with the FDA to review the supporting data as part of their ongoing commitment to innovative treatments for inflammatory bowel diseases.

Already approved for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis, TREMFYA® is the first fully-human, dual-acting monoclonal antibody targeting IL-23 and the CD64 receptor on IL-23 producing cells. The drug was first approved by the FDA in 2017 for plaque psoriasis and in 2020 for psoriatic arthritis.

Johnson & Johnson has also submitted applications to the European Medicines Agency (EMA) for expanding TREMFYA®'s indications to include ulcerative colitis and Crohn's disease.

The GALAXI program is a comprehensive global Phase 2/3 effort to evaluate TREMFYA® in patients with moderate to severe Crohn's disease who have not responded adequately to conventional therapies or biologics. The program includes a dose-ranging study (GALAXI 1) and two confirmatory Phase 3 studies (GALAXI 2 and 3), all employing a treat-through design.

Complementing GALAXI, the GRAVITI study is a randomized, double-blind, placebo-controlled Phase 3 trial focused on SC induction therapy in patients with moderate to severe Crohn's disease. The study's maintenance dosing regimens are consistent with those evaluated in the GALAXI program.

Crohn's disease is a chronic inflammatory condition affecting the gastrointestinal tract, causing symptoms like abdominal pain, diarrhea, and weight loss. Despite ongoing research, there is currently no cure for the disease, highlighting the need for effective long-term treatment options.

In summary, Johnson & Johnson's latest FDA submission for TREMFYA® could pave the way for a new, versatile treatment option for Crohn's disease, offering both SC and IV induction therapies. The robust clinical trial data supporting this submission emphasizes the potential of TREMFYA® to significantly impact the management of this challenging condition.