Ixekizumab set for EU approval for radiographic, nonradiographic axSpA
medwireNews: The EMA has adopted a positive opinion recommending approval of the interleukin (IL)-17A inhibitor ixekizumab for axial spondyloarthritis (axSpA).
This recommendation includes both the radiographic (ankylosing spondylitis) and nonradiographic forms of the disease, and follows US approval of ixekizumab for ankylosing spondylitis in 2019.
Previously approved for the treatment of psoriatic arthritis and plaque psoriasis in the EU, ixekizumab may now be given to adult patients with ankylosing spondylitis and an inadequate response to conventional therapy, as well as those with active nonradiographic axSpA and objective signs of inflammation (demonstrated by magnetic resonance imaging and/or elevated C-reactive protein) who have had an inadequate response to nonsteroidal anti-inflammatory drugs.
The efficacy of ixekizumab for ankylosing spondylitis was demonstrated in the COAST-V and COAST-W trials, which included participants who were biologic-naïve and previously treated with tumor necrosis factor inhibitors, respectively, while the IL-17A inhibitor was shown to improve the signs and symptoms of nonradiographic axSpA in the COAST-X trial.
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