Policy & Regulation
AbbVie submits SKYRIZI approval applications to US FDA and European Medicines Agency
8 April 2021 -

United States-based AbbVie (NYSE: ABBV) announced on Wednesday that it has submitted applications to the United States Food and Drug Administration (FDA) for approval of SKYRIZI (risankizumab-rzaa, 150mg) and for SKYRIZI (risankizumab, 150mg) to the European Medicines Agency (EMA), intended for the treatment of adults with active psoriatic arthritis.

The submissions were supported by two pivotal Phase three studies, KEEPsAKE-1 and KEEPsAKE-2 that assessed the product in adults with active psoriatic arthritis, including those who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs.

During the phase three KEEPsAKE-1 and KEEPsAKE-2 studies, the company says that the product indicated significant improvements in disease activity (as measured by ACR20 response and minimal disease activity), skin clearance (as measured by at least a 90% improvement in Psoriasis Area Severity Index [PASI 90]) and physical function (as measured by the Health Assessment Questionnaire Disability Index [HAQ-DI]) at week 24 compared to placebo. During both studies, significantly more patients treated with the product achieved the primary endpoint of ACR20 response at week 24 compared to placebo. The safety profile of the product in these studies was generally consistent with the safety profile of the product in plaque psoriasis, with no new safety risks observed.

SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.



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