medwireNews: The US FDA has expanded the indication of the tumor necrosis factor (TNF) inhibitor certolizumab pegol to include nonradiographic axial spondyloarthritis (axSpA) with objective signs of inflammation.
This approval “fulfills an unmet need for patients suffering from non-radiographic axial spondyloarthritis as there [have] been no FDA-approved treatments until now,” said Nikolay Nikolov, from the FDA’s Center for Drug Evaluation and Research, in a press release.
Certolizumab pegol was initially approved in 2008 and is currently used for the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, and moderate-to-severe plaque psoriasis. The expanded indication is based on the results of a phase III trial demonstrating its efficacy in 317 patients with nonradiographic axSpA.
The FDA notes that the certolizumab pegol label contains a boxed warning for serious infection risk, including tuberculosis, sepsis, and invasive fungal infections, and recommends that healthcare providers should test for latent tuberculosis before commencing treatment with the TNF inhibitor. It also cautions that certolizumab pegol is not indicated for use in children.
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