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news.Abbvie has submitted applications to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to obtain approvals for upadacitinib (RINVOQ) to treat non-radiographic axial spondyloarthritis (nr-axSpA).
AbbVie seeks FDA and EMA approval for upadacitinib to treat non-radiographic axial spondyloarthritis. Credit: Hal Gatewood on Unsplash.
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A selective JAK inhibitor, Rinvoq is currently being analysed in various immune-mediated inflammatory diseases.
Both the submissions are supported by the Phase III SELECT-AXIS 2 (Study 2) clinical study, which assessed the safety and efficacy of upadacitinib in adult nr-axSpA patients.
In this study, upadacitinib showed significant reduction in signs and symptoms of nr-axSpA, physical function as well as disease activity compared to placebo at week 14.
AbbVie chief scientific officer, research and development senior vice-president Thomas Hudson said: “Axial spondyloarthritis is a chronic inflammatory disease affecting the spine and can cause patients, who tend to be younger adults living active lives, to suffer from debilitating pain and significantly decrease their quality of life.
“AbbVie is committed to working with the FDA and EMA to make upadacitinib available as a treatment option for patients living with this disease.”
The company has also submitted the results of the Phase III SELECT-AXIS 2 clinical study (Study 1) and the Phase II/III SELECT-AXIS 1 clinical trial of upadacitinib to request label enhancements in the European Union (EU) to include adult patients with ankylosing spondylitis (AS).
To support the ongoing review of the supplemental New Drug Application (sNDA) for upadacitinib, AbbVie has also provided the data to the FDA.
RINVOQ is approved for use in moderate to severe atopic dermatitis (AD), active AS, active psoriatic arthritis (PsA), and moderate to severe active rheumatoid arthritis (RA) in the European Union.
Furthermore, the drug is approved to treat RA and PsA in the US.
