On 16 January 2025, UCB announced that it has launched in the US a high dose presentation of Bimzelx® (bimekizumab-bkzx) in a single-injection 2 mL prefilled syringe and autoinjector, each containing 320 mg of Bimzelx®. This is in addition to the currently available 1 mL (160 mg) device administration options and follows FDA approval of the presentation in October 2024.
UCB’s Bimzelx® has received several FDA approvals for new indications in recent months, including for moderate to severe hidradenitis suppurativa (November 2024), and for active psoriatic arthritis, active non-radiographic axial spondyloarthritis and active ankylosing spondylitis (September 2024).
In May 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) will consider UCB’s application to PBS-list Bimzelx® for moderate to severe hidradenitis suppurativa.