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New Indication Alert: FDA Approves Bimzelx® for Three New Indications

Sep 23, 2024

On 23 September 2024, UCB announced that its Bimzelx® (bimekizumab-bkzx) has received FDA approval for active psoriatic arthritis, active non-radiographic axial spondyloarthritis with objective signs of inflammation and active ankylosing spondylitis.  UCB reports that Bimzelx® is the first approved treatment for these three indications that is designed to selectively inhibit two key cytokines driving inflammatory processes – IL-17A and IL-17F.

This follows 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.

In March 2024, the EU’s Committee for Medicinal Products for Human Use (CHMP) recommended an indication extension for Bimzelx® for the treatment of hidradenitis suppurativa.  Bimzelx® was first approved in the EU in August 2021 for moderate to severe plaque psoriasis.