- The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending approval from AbbVie Inc ABBV Risankizumab regimen in Crohn’s disease.
- The recommendation applies to Skyrizi (600 mg intravenous induction and 360 mg subcutaneous maintenance therapy) in active Crohn’s disease who have had an inadequate response, are no longer responding, or have not tolerated conventional or biological therapy.
- Related: AbbVie psoriatic arthritis drug shows long-term effects on skin and joint symptoms.
- Three Phase 3 study dates support the endorsement. In all three studies, significantly more patients treated with risankizumab achieved the co-primary endpoints of endoscopic response and clinical remission.
- The safety results of risankizumab in Crohn’s disease were consistent with the known safety profile of risankizumab, with no new safety risks observed.
- Price promotion: ABBV shares traded 1.16% lower at $142.39 on the last check Monday.
