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Friday, November 22, 2024

J&J eyes FDA OK for subcutaneous ulcerative colitis med

 Following recent U.S. FDA approval of TREMFYA® for adults with moderately to severely active ulcerative colitis (UC), this submission underscores its potential to be the only IL-23 inhibitor that offers choice of subcutaneous or intravenous induction in UC

Submission is supported by the Phase 3 ASTRO study, which achieved the primary endpoint of clinical remission at Week 12 and met all secondary endpoints in adults with moderately to severely active UC

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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