AbbVie reports CHMP opinion recommending approval for risankizumab

AbbVie announced that the European Medicines Agency’s, or EMA’s, Committee for Medicinal Products for Human Use, or CHMP, adopted an opinion recommending the approval of risankizumab for the treatment of adults with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional or biologic therapy. The recommended induction dose is 1200 mg intravenous, followed by a maintenance dose of 180 mg or 360 mg subcutaneous, based on individual patient presentation. The final European Commission decision is expected in the third quarter of 2024.