Bimzelx (bimekizumab) receives approval in Japan for the treatment of psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis

The new indications for bimekizumab in Japan follow its first approval in January 2022 for the treatment of plaque psoriasis, generalized pustular psoriasis, and psoriatic erythroderma.

Bimekizumab is the first IL-17A and IL-17F inhibitor to receive regulatory approval in Japan for the treatment of PsA, nr-axSpA and AS in adult patients. This milestone also represents the third approval for bimekizumab in PsA, nr-axSpA and AS in 2023, following approval for these additional indications in countries of the European Union/European Economic Area and in Great Britain in June and August 2023, respectively.

Bimekizumab was approved in Japan for the treatment of adult patients with PsA. The approval is based on data from the Phase III BE COMPLETE and BE OPTIMAL studies published as back-to-back manuscripts in The Lancet (previously cited). Bimekizumab was also approved in Japan for the treatment of adult patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis. The approval is based on data from the Phase III BE MOBILE 1 and BE MOBILE 2 studies, published in Annals of the Rheumatic Diseases..The safety profile of bimekizumab in all four studies was consistent with safety data seen in previous studies with no new observed safety signals.

See;_van der Heijde D, Deodhar A, Baraliakos X, et al." Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase III randomized controlled trials". Ann Rheum Dis. 2023;82(4):515–26.