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FDA Accepts Supplemental Biologics License Applications for Bimekizumab to Treat HS


The submission stems from promising results from the phase 3 BE HEARD I and BE HEARD II trials.

FDA White Oak Campus in Silver Spring, Maryland (Tada Images/Adobe Stock)

FDA White Oak Campus in Silver Spring, Maryland (Tada Images/Adobe Stock)

UCB has announced a milestone in the treatment landscape for moderate to severe hidradenitis suppurativa (HS) with the US Food and Drug Administration (FDA) accepting for review the supplemental Biologics License Application (sBLA) for bimekizumab (Bimzelx). Alongside this application, another sBLA for the bimekizumab 2mL device presentations has also been accepted.1

The submission for bimekizumab in moderate to severe HS stems from promising results obtained from 2 phase 3 studies where bimekizumab showcased clinically meaningful improvements versus placebo at week 16, which were sustained through week 48. This development aligns with UCB's overarching goal of broadening treatment options for patients living with IL-17–mediated diseases. Christopher Sayed, MD, dermatologist at the University of North Carolina Chapel Hill’s HS clinic, served as an investigator for the phase 3 studies, BE HEARD I (NCT04242446) and BE HEARD II (NCT04242498) and shared the significance of the results with Dermatology Times in a previous interview at the 2024 American Academy of Dermatology Annual Meeting in San Diego, California.2

Key highlights from the bimekizumab data presented at AAD 2024 include significant impacts on pain3:

  • At week 48, 64.6–75.7% of patients achieved an HSSQ skin pain response.
  • HSSQ skin pain score of 0 at week 48 was achieved by 12.7–19.8% of patients.
  • From weeks 0–48, HSSQ skin pain scores reduced by 36.9–43.7% across treatment groups.
  • At week 48, 55.9–63.7% of patients rated their skin pain as "much better" using PGI-C-SP.
  • At week 48, the percentage of patients rating PGI-S-SP as "severe" decreased to 3.9–7.8%, compared to 28.5-33.3% at baseline.

The impact on draining tunnel count was also noted:

  • At week 16, bimekizumab-treated patients demonstrated a higher draining tunnel percent change from baseline compared to placebo (-43.9 to -45.7 vs -21.5%).
  • Absolute changes in draining tunnel count were greater in bimekizumab-treated patients compared to placebo.
  • The percentage and absolute change from baseline increased through week 48 across all bimekizumab groups.
  • At week 16, a greater proportion of bimekizumab-treated patients experienced draining tunnel reductions of 3 or more compared to those on placebo (58.0–70.6 vs 35.0%), with sustained or improved responses to Week 48 across regimens (79.4–88.7%).

Emmanuel Caeymaex, UCB executive vice president of immunology solutions and head of US, expressed enthusiasm regarding the progress made in the FDA applications in this morning’s news release. "The most recent sBLA seeks approval for BIMZELX in moderate to severe hidradenitis suppurativa, which reflects our commitment to enhancing patient care in this therapeutic area," said Caeymaex. Additionally, he highlighted the aim of the sBLA for the 2mL device presentations, emphasizing the desire to offer increased convenience for patients through alternative injection regimen options.

These regulatory advancements mark 2 of 5sBLAs accepted by the FDA for bimekizumab this year, following applications in psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA), and ankylosing spondylitis (AS). It's important to note that while bimekizumab was approved in the US in October 2023 for the treatment of moderate to severe plaque psoriasis in adults, it is not approved for the treatment of moderate to severe HS, PsA, nr-axSpA, and AS, or for the 2mL device presentation. The efficacy and safety of bimekizumab in these indications remain investigational.

In addition to the sBLA for HS, the application for the bimekizumab 2mL device presentations seeks approval of bimekizumab 2mL safety syringe and 2mL auto injector, aiming to provide patients with an alternative injection regimen option.

Sayed recently acknowledged the exciting advancements in HS therapies over the past decade saying “It is really exciting to see so much data come out for so many different drugs. Adalimumab (Humira) got approved almost 10 years ago at this point. Secukinumab (Cosentyx) was the next to get approved for several years. What I'm most looking forward to is the is the fact that at least some of these drugs, bimekizumab being one of them, is going to be a step up in terms of level of response. I think it's going to be reassuring that more patients respond. And when they do respond, they respond more deeply. And they hopefully maintain those responses over longer periods of time. And it's going to get more and more confusing as more drugs do come to market to figure out which drug is best for each patient. Hopefully, we get better at understanding that and predicting response to treatments, that we're not just cycling patients through a whole bunch of medications back-to-back. I think it's going to be nice to see this next step of an evolution where again, patients can expect a bit more.”


  1. FDA Accepts Supplemental Biologics License Applications for BIMZELX® (bimekizumab-bkzx) for Moderate-to-Severe Hidradenitis Suppurativa and Additional 2mL Device Presentations. News release. UCB. April 4, 2024. Accessed April 4, 2024. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/fda-accepts-supplemental-biologics-license-applications
  2. Buchanan L. Anticipated FDA approval of bimekizumab for HS: insights from investigator Christopher Sayed, MD. Dermatology Times. March 10, 2024. Accessed April 4, 2024. https://www.dermatologytimes.com/view/anticipated-fda-approval-of-bimekizumab-for-hs-insights-from-investigator-christopher-sayed-md
  3. Glatt S, Jemec GBE, Forman S, Sayed C, et al. Efficacy and safety of bimekizumab in moderate to severe hidradenitis suppurativa: a phase 2, double-blind, placebo-controlled randomized clinical trial. JAMA Dermatol. 2021 Nov 1;157(11):1279-1288. doi: 10.1001/jamadermatol.2021.2905. Erratum in: JAMA Dermatol. 2021 Nov 1;157(11):1384. PMID: 34406364; PMCID: PMC8374742.
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