AbbVie (ABBV) Submits Application for Risankizumab to the EMA

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Go back to AbbVie (ABBV) Submits Application for Risankizumab to the EMA

AbbVie Submits Application for Risankizumab (SKYRIZI®) in Moderate to Severe Crohn's Disease to European Medicines Agency (EMA)

November 30, 2021 8:05 AM EST

NORTH CHICAGO, Ill., Nov. 30, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it has submitted an application to the European Medicines Agency (EMA) seeking approval for risankizumab (SKYRIZI®, 600 mg intravenous (IV) induction and 360 mg subcutaneous (SC) maintenance therapy), an interleukin-23 (IL-23) inhibitor, for the treatment of patients 16 years and older with moderate to severe active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy. The submission is supported by three pivotal Phase 3 studies, ADVANCE, MOTIVATE and FORTIFY.1,2

"Patients with moderate to severe Crohn's... More