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05-07-2022 | Axial spondyloarthritis | News


EMA recommends approval of upadacitinib for nonradiographic axSpA

Author: Claire Barnard


medwireNews: The indication for the Janus kinase (JAK) inhibitor upadacitinib will be expanded to include nonradiographic axial spondyloarthritis (axSpA) in Europe, following a recommendation for approval by the EMA’s Committee for Medicinal Products for Human Use.

This announcement follows the results from the SELECT-AXIS 2 trial, presented at the EULAR 2022 Congress in Copenhagen, Denmark, which showed that upadacitinib has favorable efficacy and safety profiles in patients with nonradiographic axSpA with objective signs of inflammation, as well as in those with ankylosing spondylitis and an inadequate response to biologics.

The JAK inhibitor was previously approved for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and atopic dermatitis in Europe. It may now additionally be given to those with active nonradiographic axSpA who have objective signs of inflammation and an inadequate response to nonsteroidal anti-inflammatory drugs.

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