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New Indication Alert: FDA Approves UCB’s Bimzelx® (Bimekizumab-bkzx) as First IL-17A/IL-17F Inhibitor for Hidradenitis Suppurativa

Nov 20, 2024

On 20 November 2024, UCB announced that Bimzelx® (bimekizumab-bkzx) was approved by the FDA as the first IL-17A and IL-17F inhibitor for adults with moderate to severe hidradenitis suppurativa.

This follows the recommendation of the EMA’s Committee for Medicinal Products for Human Use (CHMP) of an indication extension for Bimzelx® for the treatment of hidradenitis suppurativa in March 2024, and its approval in April 2024.

In November 2024, UCB presented new two-year data from phase 3 studies of Bimzelx® showing sustained improvements in clinical and patient-reported outcomes in adults with active psoriatic arthritis and ankylosing spondylitis.