FDA Approves Bimekizumab for Adults with Hidradenitis Suppurativa

UCB has announced that US Food and Drug Administration (FDA) approved bimekizumab-bkzx (Bimzelx) for moderate-to-severe hidradenitis suppurativa (HS) treatment among adult patients.¹

This treatment is a humanized IgG1 monoclonal antibody. It is distinct as it is the first and only medication specifically formulated with the aim of targeting and inhibiting both interleukin (IL)-17A and IL-17F cytokines, blocking their interaction with the IL-17RA/IL-17RC receptor complex and impacting inflammation.

“The approval of (bimekizumab) in moderate-to-severe hidradenitis suppurativa is welcome given the substantial unmet clinical needs and limited number of treatment options available today,” Alexa B. Kimball, MD, MPH, investigator and professor of dermatology at Harvard Medical School, said in a statement. “In the Phase 3 clinical studies, patients treated with bimekizumab-bkzx achieved deep and sustained clinical responses up to 48 weeks.”¹

HS itself is a chronic inflammatory skin disease which often results in recurring symptoms including abscesses, nodules, and pus-draining tunnels in bodily areas such as the armpits, groin, and buttocks. The substantial flare-ups and pain experienced by those with HS often lead to major impacts on patients’ overall life quality.

The approval of bimekizumab to treat this condition was based upon findings resulting from two phase 3 clinical trials known as BE HEARD I and BE HEARD II.^1,2 These studies looked into the drug’s efficacy and safety among adults with moderate-to-severe disease.

The studies were double-blind, placebo-controlled analyses with enrollment of over 1,000 individuals. The set of studies used HiSCR50 as their main endpoint, defined as a minimum reduction of 50% of the total abscesses and inflammatory nodules as well as no increase in draining tunnels. They used HiSCR75 and pain reduction as key secondary measures.

Both trials indicated that a greater percentage of those given bimekizumab successfully recieved at least a 50% disease sign and symptom reduction by the 160 week mark (as measured by HiSCR50) versus those in the placebo arms of the studies. Significant improvements were also observed by the research teams in HiSCR75, with such results sustained through to the 48-week mark.

Additionally, bimekizumab’s safety profile aligned with that of the earlier studies into the drug across various indications. There were no new safety concerns.

This approval by FDA officials adds to bimekizumab’s growing list of indications, including recent approvals for active non-radiographic axial spondyloarthritis with objective signs of inflammation, psoriatic arthritis, and ankylosing spondylitis.

References

1. ^{UCB Receives U.S. FDA Approval for BIMZELX® (bimekizumab-bkzx) as the First IL-17A and IL-17F Inhibitor for Adults with Moderate-to-Severe Hidradenitis Suppurativa. UCB. November 20. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/ucb-receives-us-fda-approval-for-bimzelxr-bimekizumab-bkzx-as-the-first-il-17a-and-il-17f-inhibitor-for-adults-with-moderate-to-severe-hidradenitis-suppurativa.}
2. ^{UCB announces late-breaking two-year data for BIMZELX[®] (bimekizumab) in moderate to severe hidradenitis suppurativa at EADV 2024. September 27, 2024. https://www.ucb.com/stories-media/Press-Releases/article/UCB-announces-late-breaking-two-year-data-for-BIMZELXRVbimekizumab-in-moderate-to-severe-hidradenitis-suppurativa-at-EADV-2024. Date accessed: November 20, 2024.}