biopharmaceutical era

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On September 11th, Johnson&Johnson announced that the US FDA has approved Tremfya (guselkumab) for the treatment of moderate to severe active ulcerative colitis (UC) in adult patients. According to the press release, Tremfya is the first dual acting mechanism interleukin-23 (IL-23) inhibitor approved for the treatment of active ulcerative colitis. In the critical QUASAR project, the drug demonstrated a highly statistically significant endoscopic response rate.
The approval of Tremfya this time is supported by data from the ongoing Phase 2b/3 QUASAR study, which evaluates the efficacy and safety of Tremfya in adult patients with moderate to severe active UC who have insufficient or intolerant response to conventional therapy, other biologics, and/or JAK inhibitors.
Tremfya is a fully human monoclonal antibody. In addition to targeting IL-23, this antibody can also simultaneously bind to the receptor CD64 on IL-23 producing cells. IL-23 is a cytokine secreted by activated monocytes/macrophages and dendritic cells, and is a driving factor for immune-mediated diseases such as UC. This FDA approval is the third indication approved for Tremfya. Tremfya was first approved by the FDA for the treatment of moderate to severe plaque psoriasis in adult patients in July 2017, and subsequently approved for the treatment of active psoriatic arthritis in adult patients in July 2020. In June 2024, Johnson&Johnson submitted a supplemental biologics approval application (sBLA) to the US FDA seeking approval for Tremfya for the treatment of moderate to severe active Crohn's disease in adult patients.