New approval for UCB's Bimzelx in Japan
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Bimzelx (bimekizumab) for the treatment of adults with psoriatic arthritis (PsA), non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS) who are not sufficiently responding to existing treatments, said Belgian drugmaker UCB (Euronext: UCB) this morning.
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 interleukin (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.
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