Johnson & Johnson Reports the US FDA’s Approval of Tremfya to Treat Ulcerative Colitis
Shots:
- The US FDA has granted approval to Tremfya (guselkumab) for treating adults with moderately to severely active ulcerative colitis
- The approval was supported by the pivotal, ongoing P-IIb/III (QUASAR) study assessing the safety & efficacy of Tremfya (200mg, Q4W or 100mg, Q8W, SC) vs PBO in UC patients with inadequate response or intolerant to conventional therapy incl. JAK inhibitors
- Study showed that 50% (200mg, SC maintenance, Q4W) & 45% (100mg, SC, Q8W) vs 19% reached the 1EP of clinical remission at wk.44 with 34% (200 mg) & 35% (100 mg) vs 15% experienced endoscopic remission at 1yr.
Ref: Johnson & Johnson | Image: Johnson & Johnson
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
