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AbbVie submits applications for Rinvoq in non-radiographic axial spondyloarthritis to FDA and European Medicines Agency.

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Published:9th Jan 2022
AbbVie has announced that it has submitted applications seeking approvals for upadacitinib (Rinvoq, 15 mg once daily) to the FDA and the European Medicines Agency (EMA) for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).

In addition, AbbVie has requested label enhancements for upadacitinib in the European Union (EU) to include adult patients with active ankylosing spondylitis (AS) who had an inadequate response to biologic disease-modifying anti-rheumatic drugs (bDMARDs), based on the results of the Phase III SELECT-AXIS 2 clinical trial (Study 1), as well as two-year results of the Phase II/III SELECT-AXIS 1 clinical trial.

AbbVie also provided these data to the FDA in support of the agency's ongoing review of the supplemental New Drug Application (sNDA) for upadacitinib in AS. The safety data observed in these patients with AS or nr-axSpA were generally consistent with the known safety profile of upadacitinib. No new safety risks were identified.

Condition: Axial Spondyloarthritis
Type: drug

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