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AbbVie Submits Applications For Upadacitinib In Non-Radiographic Axial Spondyloarthritis To FDA

AbbVie (ABBV) said Friday that it has submitted applications seeking approvals for upadacitinib (RINVOQ, 15 mg once daily) to the U.S. Food and Drug Administration and the European Medicines Agency 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).

Axial spondyloarthritis is a chronic inflammatory disease that affects the spine, causing back pain, limited mobility, and structural damage.

AbbVie said it has also submitted results from two studies of upadacitinib in adult patients with ankylosing spondylitis (AS) to request label enhancements in the European Union.

RINVOQ is approved for use in active psoriatic arthritis (PsA), moderate to severe active rheumatoid arthritis (RA), moderate to severe atopic dermatitis (AD) and active AS in the EU, and for PsA and RA in the U.S.

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