AbbVie submits regulatory application to FDA for Skyrizi (risankizumab-rzaa) subcutaneous induction for adults with moderately to severely active Crohn's disease

AbbVie

27 April 2026 - Submission supported by data from Phase 3 pivotal AFFIRM study.

AbbVie today announced that it has submitted an application to the US FDA seeking approval for Skyrizi (risankizumab-rzaa) for subcutaneous induction for the treatment of adult patients with moderately to severely active Crohn's disease.

Read AbbVie press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier , Registration