FDA Acceptance Announced of sBLA for Bimekizumab HS Treatment, 2mL Administration Devices

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The FDA announcement on bimekizumab’s supplemental Biologics License Application followed the phase 3 BE HEARD I and II studies’ conclusion.

An announcement was made by biopharmaceutical company UCB on the US Food and Drug Administration’s (FDA) decision to accept the supplemental Biologics License Application (sBLA) for bimekizumab-bkzx (Bimzelx) treatment of hidradenitis suppurativa (HS) as well as another sBLA for bimekizumab 2mL device presentations.1

Bimekizumab is an inhibitor of IL-17A and IL-17F is intended for adult patients with moderate-to-severe HS, specifically. HS is a chronic skin disease known to cause recurring, painful, and debilitating skin inflammation, leading to abscesses, nodules, and pus-discharging tunnels during severe flare-ups and impacting mostly those in early adulthood.

"We are excited to share progress on our FDA applications,” Emmanuel Caeymaex, executive vice president of immunology solutions and head of US at UCB, said in a statement. “The most recent sBLA seeks approval for (bimekizumab) in moderate-to-severe hidradenitis suppurativa, and is aligned to our goal of expanding the reach of (bimekizumab) to more patients living with IL-17–mediated diseases.”

A total of five sBLAs have been accepted by FDA officials in 2024, with prior applications of the drug having been submitted for treatment of non-radiographic axial spondyloarthritis (nr-axSpA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS).

While the drug has been given FDA approval in October 2023 for moderate-to-severe plaque psoriasis treatment of adults who are eligible for systemic therapy or phototherapy, it has yet to be approved for moderate-to-severe PsA, HS, nr-axSpA, and AS, or for the 2mL device presentation, as these areas are still in the investigational stage.2

UCB’s sBLA for treatment of HS was based upon results of the phase 3 BE HEARD I and BE HEARD II trials, as both studies ended up with clinically meaningful improvements being observed by investigators in HiSCR50 as opposed to placebo at the 16-week mark, which represented the primary endpoint of the trials.1 The studies enrolled over 1,000 participants.

HiSCR75 was also observed in a greater proportion of participants treated with bimekizumab by the same 16-week mark, representing the achievement of a key secondary endpoint. The research team had then observed a continuation of improvements over 48 weeks for subjects, adding that the safety data was consistent with prior research and that there were no new safety concerns.

The new sBLA for additional device presentations was designed for UCB to receive an approval for the bimekizumab 2mL safety syringe and 2mL autoinjector. These would allow for an alternative to the currently-approved 1mL presentations.

"In addition, the sBLA for the 2mL device presentations aims to offer increased convenience for patients,” Caeymaex said in the same statement. “Today, one dose of (bimekizumab) in moderate-to-severe plaque psoriasis is administered as two 1mL injections. Approval of the 2mL device presentations would mean that patients would have an alternative one-injection regimen option."

References

  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. https://www.prnewswire.com/news-releases/fda-accepts-supplemental-biologics-license-applications-for-bimzelx-bimekizumab-bkzx-for-moderate-to-severe-hidradenitis-suppurativa-and-additional-2ml-device-presentations-302107800.html. Date accessed: April 4, 2024.
  2. Kunzmann K. FDA Approves Bimekizumab for Adults with Plaque Psoriasis. HCPLive. October 18, 2023. https://www.hcplive.com/view/fda-approves-bimekizumab-adults-plaque-psoriasis. Date accessed: April 4, 2024.
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