▎WuXiEdited by Kant Content Team

Johnson & Johnson announced today that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. FDA, seeking approval for its anti-IL-23 antibody Tremfya (guselkumab) as a subcutaneous (SC) induction regimen for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).

This application is based on the positive data from the Phase 3 ASTRO study, which evaluated the efficacy and safety of Tremfya subcutaneous injection as an induction therapy for UC.The patient received 400 mg Tremfya subcutaneous injection induction therapy at weeks 0, 4, and 8.Analysis showed that patients achieved statistically significant and clinically meaningful clinical remission at week 12, meeting the primary endpoint of the trial. In addition, patients also met all secondary endpoints, including endoscopic improvement and histologic-endoscopic mucosal improvement (HEMI).The safety data from the ASTRO study are consistent with the results from previous trials.

Tremfya was approved in September 2024.FDA Approval, asIntravenous (IV) Induction RegimenFor the treatment of adult patients with moderate to severe active UC, followed by subcutaneous injection for maintenance therapy. This approval is based on data from the Phase 3 QUASAR study, which demonstrated the efficacy and safety of Tremfya in UC patients. Additionally, Tremfya is used to treat moderate to severe activeCrohn's DiseaseThe application for (CD) has been submitted to the U.S. FDA, while the applications for UC and CD have also been submitted to European regulatory authorities.

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 it is a driving factor in immune-mediated diseases such as UC.

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References:

[1] Johnson & Johnson seeks U.S. FDA approval for subcutaneous induction regimen of TREMFYA® (guselkumab) in ulcerative colitis, a first for an IL-23 inhibitor. Retrieved November 22, 2024 from https://www.prnewswire.com/news-releases/johnson--johnson-seeks-us-fda-approval-for-subcutaneous-induction-regimen-of-tremfya-guselkumab-in-ulcerative-colitis-a-first-for-an-il-23-inhibitor-302313913.html

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