AbbVie’s Rinvoq (upadacitinib) Receives the EC’s Approval for Psoriatic Arthritis and Ankylosing Spondylitis

Shots:

• The approval is based on data from three pivotal clinical trials P-II SELECT-PsA 1& 2 and P-II/III SELECT-AXIS 1 involves assessing of Rinvoq in patients with PsA and AS. The studies demonstrated that it met all 1EPs & 2EPs with a safety profile consistent with that seen in RA
• The P-III studies met its 1EPs of ACR20 @12wks., showed non-inferiority to adalimumab for ACR 20 @12wks. The P-II/III study met 1EPs od ASAS 40 @15wks
• Rinvoq (15mg, PO, qd) is a selective and reversible JAK inhibitor, approved for three adult rheumatic indications in the EU: RA, PsA, AS

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