FDA Accepts sBLA for Bimzelx to Treat Hidradenitis Suppurativa Based on Phase III Trial Data


In the Phase III BE HEARD I and BE HEARD II trials, a greater proportion of patients with moderate-to-severe hidradenitis suppurativa who were administered Bimzelx achieved the primary endpoint of clinically meaningful improvements in HiSCR50.

Image credit: Kristina Blokhin | stock.adobe.com

Image credit: Kristina Blokhin | stock.adobe.com

The FDA has accepted a supplemental Biologics License Application (sBLA) for Bimzelx (bimekizumab-bkzx) to treat adults with moderate-to-severe hidradenitis suppurativa (HS), as well as an additional sBLA for 2 mL Bimzelx device presentations.1

The humanized monoclonal IgG1 antibody was developed to selectively inhibit interleukin (IL)-17A and IL-17F, two cytokines that affect inflammatory processes. Bimzelx was approved by the FDA in October 2023 for adults with moderate to severe plaque psoriasis who are eligible for systemic therapies or phototherapies. It was the first and only approved psoriasis treatment that selectively inhibits IL-17A and IL17F.2

“We are excited to share progress on our FDA applications. The most recent sBLA seeks approval for Bimzelx in moderate-to-severe hidradenitis suppurativa, and is aligned to our goal of expanding the reach of Bimzelx to more patients living with IL-17–mediated diseases,” Emmanuel Caeymaex, executive vice president, Immunology Solutions, and head of US, UCB, said in a press release. “In addition, the sBLA for the 2 mL device presentations aims to offer increased convenience for patients. Today, one dose of Bimzelx in moderate-to-severe plaque psoriasis is administered as two 1 mL injections. Approval of the 2 mL device presentations would mean that patients would have an alternative one-injection regimen option.”1

In February 2024, UCB filed multiple sBLAs for Bimzelx across three new indications for psoriatic arthritis, non-radiographic axial spondylarthritis, and ankylosing spondylitis.3

The sBLA for moderate-to-severe HS was based on findings from the randomized, double-blind, placebo-controlled, parallel group, multicenter Phase III BE HEARD I (NCT04242446) and BE HEARD II (NCT04242498) trials.

Both trials enrolled a combined 1,014 patients with moderate-to-severe HS. The primary endpoint for both BE HEARD I and BE HEARD II was Hidradenitis Suppurativa Clinical Response (HiSCR)50 at week 16, with a key secondary endpoint of HiSCR75 at week 16. Both HiSCR50 and HiSCR75 are defined as at least a 50% or 75% percent decrease, respectively, from baseline in the total abscess and inflammatory nodule count and no increase from baseline in abscess or draining tunnel count.

Investigators found that a greater proportion of patients administered Bimzelx achieved the primary endpoint of clinically meaningful improvements in HiSCR50 at week 16 compared with placebo. Further, a greater proportion of patients administered Bimzelx achieved HiSCR75 at week 16 compared with placebo. Over 48 weeks, investigators found that these improvements increased across both trials for patients in the Bimzelx cohorts.

Between 69.5% and 74.8% of patients achieving HiSCR50 at week 16 reported a quality-of-life rating of “none or mild” at week 16. A greater proportion of patients reported the “none or mild” rating if they achieved HiSCR75 (77.2%-84.3%) or HiSCR90 (80.0%-89.3%) at week 16, with similar findings observed at week 48.3

In terms of safety, the profile of Bimzelx was consistent with prior trials and no new safety signals were reported. UCB said that it expects FDA action and potential approvals for the multiple sBLA indications by the end of 2024.


1. FDA Accepts Supplemental Biologics License Applications for BIMZELX® (bimekizumab-bkzx) for Moderate-to-Severe Hidradenitis Suppurativa and Additional 2mL Device Presentations. 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. BIMZELX Approved by the U.S. FDA for the Treatment of Adults with Moderate-to-Severe Plaque Psoriasis. UCB. News release. October 18, 2023. Accessed April 4, 2024. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/bimzelx-approved-by-the-us-fda-for-the-treatment-of-adults-with-moderate-to-severe-plaque-psoriasis

3. Latest analyses of bimekizumab phase 3 studies in moderate to severe hidradenitis suppurativa to be presented at EHSF 2024. UCB. News release. February 9, 2024. Accessed April 4, 2024. https://www.ucb.com/stories-media/Press-Releases/article/Latest-analyses-of-bimekizumab-phase-3-studies-in-moderate-to-severe-hidradenitis-suppurativa-to-be-presented-at-EHSF-2024

Related Content
© 2024 MJH Life Sciences

All rights reserved.