Certolizumab for axial spondylo- arthritis in CanadaMarch 6, 2020
Health Canada has approved certolizumab pegol for the treatment of adults with severe active non-radiographic axial spondyloarthritis (nr-axSpA), UCB Canada Inc announced.
Certolizumab pegol is a pegylated monoclonal antibody against tumour necrosis factor-alpha (TNF-alpha).
Health Canada’s approval is based on data from C-AXSPAND5, a phase 3, multi-centre, double-blind, placebo-controlled 52-week study that randomised 317 adult patients to receive either certolizumab or placebo plus common background medications, which included NSAIDs, corticosteroids, analgesics and slow-acting anti-rheumatic drugs.
The US FDA approved certolizumab for the treatment of Crohn’s disease in people who did not respond sufficiently or adequately to standard therapy in 2015.