On 14 November 2024, UCB announced the presentation of new two-year data from phase 3 studies of Bimzelx® (bimekizumab-bkzx) showing sustained improvements in clinical and patient-reported outcomes in adults with active psoriatic arthritis (PsA) and ankylosing spondylitis (AS). The data demonstrated that, of responders who achieved at least 50% improvement from baseline response criteria for PsA, 75% maintained response to two years. Of patients who achieved a 40% improvement in response criteria for AS, 85% maintained this response to two years.
This follows FDA approval of 2 mL pre-filled syringe and pre-filled autoinjector presentations in October 2024, each containing 320 mg of Bimzelx®, 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.