AbbVie: RINVOQ Approved In EU To Treat Adults With Active Non-Radiographic Axial Spondyloarthritis

AbbVie (ABBV) announced Friday that the European Commission has approved RINVOQ (upadacitinib 15 mg, once daily) as an oral treatment for adults with Active Non-Radiographic Axial Spondyloarthritis or axSpA.

axSpA is a chronic, progressive and disabling inflammatory rheumatic disease that causes joint inflammation, leading to back pain and stiffness.

With this approval, RINVOQ is the first and only Janus Kinase or JAK inhibitor approved to treat patients across the spectrum of axial spondyloarthritis in the European Union.

The approval is for the treatment of active non-radiographic axial spondyloarthritis or nr-axSpA in adult patients with objective signs of inflammation, as indicated by elevated C-reactive protein or CRP and/or magnetic resonance imaging or MRI, who have responded inadequately to nonsteroidal anti-inflammatory drugs or NSAIDs.

The company noted that the approval is supported by data from the Phase 3 SELECT-AXIS 2 pivotal clinical trial in which RINVOQ delivered meaningful disease control with nearly half of nr-axSpA patients achieving ASAS40 at week 14 compared to placebo.

AbbVie previously disclosed topline results from the Phase 3 SELECT-AXIS 2 nr-axSpA clinical trial and the full results have been published in The Lancet.

With the EC Marketing Authorization for nr-axSpA, RINVOQ is approved in all member states of the European Union, as well as Iceland, Liechtenstein, Northern Ireland and Norway.

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