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Approval Alert: UCB’s Bimzelx® (Bimekizumab) Receives Korean Approval for Moderate to Severe Plaque Psoriasis

Aug 30, 2024

On 30 August 2024, Korea Biomedical Review reported that UCB’s Bimzelx® (bimekizumab) has received approval from the Korean Ministry of Food and Drug Safety as a treatment for moderate to severe adult plaque psoriasis.  UCB says that Bimzelx® is the only treatment for plaque psoriasis that simultaneously inhibits the IL-17A and IL-17F cytokines which play a pivotal role in inducing inflammation.

In April this year, Australia’s PBAC recommended Bimzelx® for listing on the PBS for severe psoriatic arthritis.  We reported in August 2024 that Bimzelx® is potentially in line for listing on Australia’s PBS for psoriatic arthritis and ankylosing spondylitis, having now progressed to the last stage before listing.  Bimzelx® is already listed on the PBS for chronic plaque psoriasis.

In March 2024, the EU’s Committee for Medicinal Products for Human Use 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.