Press releases

Immunology

TREMFYA® (guselkumab) is the first and only IL-23 inhibitor to demonstrate robust results with a fully subcutaneous regimen in both induction and maintenance in Crohn’s disease

October 28, 2024

United States

Immunology

TREMFYA® (guselkumab) demonstrates impressive results across biologic-naïve and biologic-refractory patients in Crohn’s disease and ulcerative colitis

October 10, 2024

Austria

Immunology

TREMFYA^® (guselkumab) receives U.S. FDA approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson’s leadership in inflammatory bowel disease

The first and only dual-acting interleukin-23 inhibitor approved in active ulcerative colitis, TREMFYA® showed highly statistically significant rates of endoscopic remission at one year in the pivotal QUASAR program1,2,3,4,5

TREMFYA® is now approved for the treatment of plaque psoriasis, active psoriatic arthritis and ulcerative colitis

September 11, 2024

United States

Immunology

Johnson & Johnson submits application to U.S. FDA seeking approval of TREMFYA^®(guselkumab) for the treatment of moderately to severely active Crohn’s disease

Submission is supported by 48-week results from the Phase 3 GALAXI and GRAVITI programs

TREMFYA^® is the only IL-23 inhibitor to demonstrate strong endoscopic outcomes with subcutaneous (SC) induction, consistent with intravenous (IV) induction, and has the potential to be the first in its class to offer the option of both SC and IV induction therapy in Crohn’s disease

GALAXI includes data demonstrating superior outcomes for TREMFYA^® versus STELARA^® (ustekinumab) in Crohn’s disease

June 21, 2024

Immunology

TREMFYA^® (guselkumab) studies underscore its potential to be the only IL-23 inhibitor to offer both subcutaneous and intravenous induction

TREMFYA^® Phase 3 Crohn’s disease study achieves all primary and secondary endpoints

June 20, 2024

Immunology

TREMFYA® (guselkumab) demonstrates superiority versus STELARA® (ustekinumab) in Phase 3 Crohn’s disease program

Data from GALAXI 2 & 3 showed TREMFYA® was superior to STELARA ® in all pooled endoscopic endpoints

May 21, 2024

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