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AbbVie Submits Regulatory Applications for SKYRIZI® in Psoriatic Arthritis to FDA and EMA


ABBVie  today announced that it has submitted applications seeking approval for SKYRIZI ® to the U.S. Food and Drug Administration and for SKYRIZI ® to the European Medicines Agency  for the treatment of adults with active psoriatic arthritis. 1 The submissions were supported by two pivotal Phase 3 studies, KEEPsAKE-1 and KEEPsAKE-2, which evaluated SKYRIZI in adults with active psoriatic arthritis including …
ABBVie (NYSE: ABBV) today announced that it has submitted applications seeking approval for SKYRIZI ® (risankizumab-rzaa, 150 mg) to the U.S. Food and Drug Administration (FDA) and for SKYRIZI ® (risankizumab, 150 mg) to the European Medicines Agency (EMA) for the treatment of adults with active psoriatic arthritis. 1 The submissions were supported by two pivotal Phase 3 studies, KEEPsAKE-1 and KEEPsAKE-2, which evaluated SKYRIZI in adults with active psoriatic arthritis including those who had responded inadequately or were intolerant to biologic therapy andor ....

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