US-based Johnson & Johnson (J&J; NYSE: JNJ) announced the commercial launch of Tremfya (guselkumab) intravenous (IV) infusion in China. The therapy is indicated for adult patients with moderate to severe active Crohn’s disease (CD) and ulcerative colitis (UC) who have had an insufficient response, loss of response, or intolerance to traditional treatments or biologics.
Tremfya’s Previous Approvals
Tremfya, a monoclonal antibody targeting interleukin-23, was previously approved in China for moderate to severe plaque psoriasis via subcutaneous injection. It also received approval for CD and UC in the same delivery form.
New IV Formulation and Clinical Support
The IV formulation of Tremfya received approval for CD in February and UC in April of this year. The Phase III GALAXI and QUASAR studies provided the evidence needed for these approvals, demonstrating Tremfya’s efficacy in improving endoscopic remission rates in patients with CD and UC.-Fineline Info & Tech
