Shots:
- The EC has approved Tremfya to treat mod. to sev. active UC adults with inadequate response, no response or intolerance to SoCs or biologics; CHMP recommendation under EC review for mod. to sev. active Crohn’s disease with decision anticipated later 2025
- Approval was based on P-IIb/III (QUASAR) trial assessing Tremfya (IV induction: 200mg Q4W; SC maintenance: 100mg at Wk. 16 then Q8W or 200mg at Wk. 12 then Q4W for inadequate response) vs PBO in UC pts
- Study showed that 50% (200mg, SC) & 45% (100mg, SC) vs 19% reached the 1EP of clinical remission with 34% (200mg, SC) & 35% (100mg, SC) vs 15% achieving endoscopic remission at Wk. 44
Ref: Johnson & Johnson | Image: Johnson & Johnson
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