United States-based pharmaceutical company AbbVie (NYSE: ABBV) announced on Friday that it has received approval from the European Commission (EC) for its RINVOQ (upadacitinib 15mg, once daily), an oral therapy, intended to treat 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).
The approval means that RINVOQ is approved in all member states of the European Union and Iceland, Liechtenstein, Northern Ireland and Norway.
Thomas Hudson, M.D., senior vice president of research and development, chief scientific officer, AbbVie, said, 'For years, healthcare providers and patients have had limited treatment options to manage axial spondyloarthritis, which can cause back pain, stiffness, and irreversible damage to the spine. AbbVie is proud to offer RINVOQ as a first-in-class treatment option now approved in the European Union for adults living with nr-axSpA with objective signs of inflammation and inadequate response to NSAIDs. RINVOQ is the first and only JAK inhibitor approved to treat patients across the spectrum of axial spondyloarthritis, which includes nr-axSpA and ankylosing spondylitis.'
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