AbbVie submits applications for Rinvoq in non-radiographic axial spondyloarthritis to FDA and European Medicines Agency.
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.
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AbbVie announced that the European Commission (EC) has approved Rinvoq (upadacitinib 15 mg, once daily), an oral therapy, for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in adult patients with objective signs of inflammation, as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).
AbbVie announced the presentation of full results from two studies from the Phase III SELECT-AXIS 2 program evaluating upadacitinib (Rinvoq) , an oral therapy, in adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) and patients with treatment-refractory active ankylosing spondylitis (AS) with an inadequate response (IR) to biologic disease-modifying antirheumatic drugs (bDMARDs).
Abbvie has filed its JAK inhibitor Rinvoq (upadacitinib) in Japan for an additional indication of non-radiographic axial spondyloarthritis (nr-axSpA) in adult patients who have responded inadequately to existing treatments.