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While the entire class of JAK inhibitors has faced safety concerns in the U.
Recently, the company announced that it has submitted new indication applications for Rinvoq to regulatory agencies in the United States and Europe for the treatment of radiologically negative axial spondyloarthritis (nr-axSpA), which is specifically indicated for: nr-axSpA patients with insufficient response to inflammatory drugs and objective signs of inflammation
For now, AbbVie is counting on Rinvoq and another rookie in immunology, Skyrizi, to cushion the blow when Humira biosimilars hit the U.
Rinvoq's active pharmaceutical ingredient is upadacitinib, an oral selective and reversible JAK1 inhibitor discovered and developed by AbbVie that is being developed to treat several immune-mediated inflammatory diseases
In the United States, Rinvoq has been approved for the treatment of rheumatoid arthritis (RA) and psoriatic arthritis (PsA)
Axial spondyloarthritis (axSpA) is a chronic inflammatory disease affecting the spine that can cause patients to suffer from debilitating pain and significantly reduce their quality of life
In addition to the nr-axSpA indication application, AbbVie is seeking a European label expansion for Rinvoq to increase adult patients with "active AS who have had an inadequate response to biological disease-modifying antirheumatic drugs (bDMARDs)
As for nr-axSpA, AbbVie said in the announcement that it is using data from Select-Axis 2, in which Rinvoq met the primary endpoint and multiple secondary endpoints
In these trials, Rinvoq's safety profile was "generally consistent" with the drug's known safety profile, and no new safety risks emerged
Last September, the U.
For now, AbbVie is counting on two next-generation immunology drugs, Rinvoq and Skyrizi, to maintain market leadership after flagship Humira faces a patent cliff in the U.
The 2 drugs have made impressive progress in 2021
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