On 14 October 2024, UCB announced that the US FDA has approved a 2 mL pre-filled syringe and pre-filled autoinjector, each containing 320 mg of Bimzelx® (bimekizumab-bkzx), adding to the already approved 1 ml (160 mg) device presentation.
On 23 September 2024, UCB received FDA approval for three new indications of Bimzelx®, including active psoriatic arthritis, active non-radiographic axial spondyloarthritis with objective signs of inflammation and active ankylosing spondylitis. This followed US approval of Bimzelx® in October 2023 for moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
In April 2024, Australia’s PBAC recommended Bimzelx® for listing on the PBS for severe psoriatic arthritis. Bimzelx® is also potentially in line for PBS-listing for psoriatic arthritis and ankylosing spondylitis, having previously been listed for chronic plaque psoriasis.