J&J Tremfya label expanded in the U.S. for inflammatory bowel disease

Johnson & Johnson (NYSE:JNJ) has received the U.S. FDA approval to expand the label of its dual-acting monoclonal antibody Tremfya (guselkumab) to include adults with moderately to severely active ulcerative colitis, a form of inflammatory bowel disease.

The blockbuster was first approved in the U.S. for adults with moderate-to-severe plaque psoriasis in 2017. Subsequently, in 2020, its labeling was expanded to include adults with active psoriatic arthritis.

Its latest approval is backed by data from J&J’s (JNJ) ongoing Phase 2b/3 QUASAR study, which reached the primary endpoint when UC patients on subcutaneous (SC) Tremfya showed statistically significant rates of endoscopic remission at Week 44.

“In the QUASAR clinical program, TREMFYA demonstrated high reported rates of endoscopic remission at one year of treatment, continuing to raise the bar for efficacy in the treatment of this inflammatory bowel disease,” said Christopher Gasink, a Vice President of medical affairs at J&J (JNJ) Innovative Medicine.