AbbVie’s Skyrizi (Risankizumab) Receives the EC’s Approval to Treat Moderate to Severe Active Ulcerative Colitis
Shots:
- The EC approved Skyrizi (induction dose: 1,200mg, IV, wks.0, 4 & 8; maintenance dose: 180mg/360mg, SC, first at wk.12 then Q8W) for moderate to severe active UC adults, not responding or intolerant to conventional/biologic therapy
- Approval was based on 2 P-III UC studies, INSPIRE assessing Skyrizi vs PBO as induction therapy for 12wks. and COMMAND assessing it as maintenance therapy vs withdrawal from treatment (control) for 52wks.
- Both studies met their 1EP of clinical remission (INSPIRE: 20% vs 6%; COMMAND: 40% & 38% vs 25%) & 2EPs of mucosal healing [INSPIRE: 37% vs 12% & 48% vs 14% (without JAK inhibitor failure); COMMAND: 51% & 48% vs 32% and 60% & 76% vs 36% (without JAK inhibitor failure)] and HEMH (INSPIRE: 24% vs 8%; COMMAND: 43% & 42% vs 23%)
Ref: AbbVie | Image: AbbVie
Related News:- AbbVie's Skyrizi Gains the US FDA’s Approval for Treating 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.
