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Thursday, June 20, 2024

J&J seeking approval of TREMFYA for Crohn's disease

 Submission is supported by 48-week results from the Phase 3 GALAXI and GRAVITI programs

TREMFYA® is the only IL-23 inhibitor to demonstrate strong endoscopic outcomes with subcutaneous (SC) induction, consistent with intravenous (IV) induction, and has the potential to be the first in its class to offer the option of both SC and IV induction therapy in Crohn's disease

GALAXI includes data demonstrating superior outcomes for TREMFYA® versus STELARA® (ustekinumab) in Crohn's disease

https://www.prnewswire.com/news-releases/johnson--johnson-submits-application-to-us-fda-seeking-approval-of-tremfya-guselkumab-for-the-treatment-of-moderately-to-severely-active-crohns-disease-302178478.html

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