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 non-b
AbbVie Submits Regulatory Applications for SKYRIZI® (risankizumab) in Psoriatic Arthritis to FDA and EMA
- Submissions supported by two Phase 3 studies in patients with active psoriatic arthritis in which SKYRIZI demonstrated improved skin and joint symptoms and physical function, with a greater proportion of patients achieving minimal disease activity versus placebo[1]
- In the pivotal studies, patients treated with SKYRIZI received four maintenance doses a year, following two initiation doses[1]
- Psoriatic arthritis is a systemic inflammatory disease that impacts the skin and joints, affecting approximately 30 percent of patients with psoriasis[2-5]
- AbbVie remains committed to working with regulatory authorities to bring SKYRIZI to more patients living with immune-mediated diseases