AbbVie's Skyrizi Gains the US FDA’s Approval for Treating Ulcerative Colitis
Shots:
- The US FDA has granted approval to Skyrizi (IL-23 antagonist) for the treatment of moderately to severely active ulcerative colitis in adults
- The approval was based on two P-III UC studies, INSPIRE that assessed Skyrizi’s (1200mg, IV, Q4W) safety & efficacy as induction therapy for 12wks. and COMMAND that evaluated Skyrizi (180mg/360mg, SC, Q8W) as maintenance therapy for 52wks.
- The two studies reached their 1EP of clinical remission [INSPIRE: 20.3% vs 6.2%; COMMAND: 40% (180mg) & 38% (360mg) vs 25%] as well as 2EP of endoscopic improvement (INSPIRE: 36.5% vs 12.1%; COMMAND: 51% & 48% vs 32%)
Ref: AbbVie | Image: AbbVie
Related News:- AbbVie Reports the CHMP’s Positive Opinion of Skyrizi (Risankizumab) to Treat Ulcerative Colitis
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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.
