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- 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 2 & 3 (IV induction: 200mg Q4W; SC maintenance) vs Stelara; MAA of SC Tremfya for mod. to sev. UC under EMA’s review based on P-III (ASTRO) trial
- In GRAVITI, 56% & 41% had clinical & endoscopic remission, respectively vs 21% at Wk. 12; At Wk. 48, 60% (100mg) & 66.1% (200mg) vs 17.1% (PBO) had clinical remission, with 44.3% & 51.3% vs 6.8% showing endoscopic response
- In pooled GALAXI 2 & 3 trials, SC maintenance at Wk. 48 showed endoscopic response in 48% (100mg) & 53% (200mg) vs 37% on Stelara, with clinical remission in 25% & 21% vs 16% pts
Ref: GlobeNewswire | Image: Johnson & Johnson
Related News:- Johnson & Johnson’s Tremfya Receives the EC’s Approval for Active Ulcerative Colitis (UC)
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