AbbVie Submits Regulatory Applications to the US FDA and EMA for Skyrizi (risankizumab) to Treat Psoriatic Arthritis

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  • The submission is based on two P-III studies KEEPsAKE-1 & -2 studies involves assessing Skyrizi (150mg) vs PBO in adult patients with active PsA who had an inadequate response or intolerant to biologic therapy and/or non-biologic DMARDs respectively
  • The 1EP and 2EP of both studies showed ACR20 response @24wks., improvements in disease activity, skin clearance, 90% improvement in PASI 90 & physical function as measured by HAQ-DI
  • The safety profile was generally consistent with the known profile of Skyriz in psoriasis patients, with no new safety risks observed. Skyrizi is an IL-23 inhibitor, being developed in collaboration with Boehringer Ingelheim

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