Johnson & Johnson Reports the US FDA’s Approval of Subcutaneous & Intravenous Tremfya for Active Crohn’s Disease (CD)
Shots:
- Approval was based on P-III trials, incl. GRAVITI (SC induction: 400mg Q4W; maintenance: 200mg at Wk. 12 then Q4W or 100mg at Wk. 16 then Q8W) vs PBO, & GALAXI (IV induction: 200mg Q4W; SC maintenance) vs Stelara
- At Wk. 12, 56% vs 22% achieved clinical remission in GRAVITI, while GALAXI 2 & 3 showed 47% vs 20% & 47% vs 15%, respectively, plus endoscopic responses were 34% vs 15% (GRAVITI), 36% vs 9% (GALAXI 2), & 34% vs 13% (GALAXI 3)
- At Wk. 48, maintenance showed sustained effects, with GRAVITI (Q8W) showing clinical remission: 59% vs 17%, endoscopic response: 39% vs 5%, endoscopic remission: 31% vs 6%, & deep remission: 26% vs 4%, while GALAXI 3 (Q4W) rates were 65% vs 17%, 48% vs 5%, 40% vs 6%, & 34% vs 4%, respectively
Ref: Johnson & Johnson | Image: Johnson & Johnson
Related News:- Johnson & Johnson Highlights P-III Clinical Data of Icotrokinra for Plaque Psoriasis at AAD 2025
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Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.
