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FDA approved Bimzelx for the treatment of hidradenitis
Last reviewed: 02.07.2025
The U.S. Food and Drug Administration (FDA) has approved UCB's Bimzelx (bimekizumab-bkzx) to treat adults with moderate to severe hidradenitis suppurativa.
Bimzelx is the first and only approved drug that selectively inhibits interleukin 17F (IL-17F) in addition to interleukin 17A (IL-17A). This is the fifth indication for Bimzelx in the United States.
Basis for approval:
The approval is based on data from two Phase III clinical trials (BE HEARD I and BE HEARD II) conducted in adult patients with moderate to severe hidradenitis suppurativa.
Key performance indicator:
- HiSCR50: At week 16, a significantly greater proportion of patients treated with Bimzelx achieved ≥50% improvement in signs and symptoms of hidradenitis suppurativa (as measured by the Hidradenitis Suppurativa Clinical Response (HiSCR50) score) compared with placebo.
Secondary indicator:
- HiSCR75: The drug also provided clinically meaningful improvements in patients achieving ≥75% improvement (HiSCR75) at week 16, compared with placebo.
Sustainability of results:
- Clinical responses were maintained through week 48, with no new safety signals identified.
Expert opinion:
Dr. Alexa B. Kimball, BE HEARD program investigator and dermatologist at Beth Israel Deaconess Medical Center in Boston, said,
“The approval of Bimzelx for the treatment of moderate-to-severe hidradenitis suppurativa is an important development given the significant unmet clinical need and limited number of treatment options available today.”