AbbVie’s Skyrizi Receives the EC’s Approval for the Treatment of Moderate to Severe Active Crohn's Disease
Shots:
- The approval was based on the data from the 3 P-III clinical studies (ADVANCE/MOTIVATE induction & FORTIFY maintenance) evaluating the safety, efficacy & tolerability of Skyrizi vs PBO as induction (600-1200mg) & maintenance (180-360mg) therapy in patients with moderately/severely active Crohn's disease
- The patients treated with Skyrizi (600mg, IV) in the induction trials depicted a clinical remission of (43% & 35%) & an endoscopic response in (40% & 29%) @12wks vs (22% & 19%) & (12% & 11%) in PBO whereas those treated with Skyrizi (360mg, SC) in the maintenance trial depicted a clinical remission of 52% & an endoscopic response of 47% @52wks. vs 40% & 22% in PBO
- The induction trials showed mucosal healing & endoscopic remission in (21% & 14%) & (24% & 19%) of patients @12wks. vs (8% & 4%) & (9% & 4%) in PBO whereas for that in the maintenance trial the number was 31% & 39% vs 10% & 13% @52wks.
Ref: AbbVie | Image: AbbVie
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
