UCB’s Bimzelx Receives FDA Approval for Moderate-to-Severe Hidradenitis Suppurativa, Marking Fifth Indication

FDA Approval:
The U.S. Food and Drug Administration (FDA) has approved Bimzelx (bimekizumab-bkzx) for the treatment of adults with moderate-to-severe hidradenitis suppurativa (HS), a chronic and painful inflammatory skin disease[1][2][3].

Clinical Trials:
The approval is supported by data from two Phase 3 studies, BE HEARD I and BE HEARD II, which demonstrated that Bimzelx improved the signs and symptoms of HS compared to placebo at Week 16, with sustained clinical responses up to Week 48[1][2][3].

Mechanism of Action:
Bimzelx is the first and only approved medicine designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), cytokines critical to the inflammatory processes underlying HS[1][2][3].

Unmet Needs:
The approval addresses substantial unmet clinical needs and limited treatment options for HS, offering a new possibility for the treatment of people in the U.S. living with moderate-to-severe disease[1][2][3].

Fifth Indication:
This marks the fifth FDA-approved indication for Bimzelx in the U.S., following approvals for moderate-to-severe plaque psoriasis, active psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis[1][2][3].

Impact:
The approval underscores UCB's commitment to addressing unmet needs in HS and other immunological conditions, delivering innovative medicines, and raising standards of care[1][2][3].