FDA Approves 320 mg Bimekizumab Pre-Filled Syringe and Autoinjector

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UCB announced this week advancements in the delivery options for bimekizumab-bkzx (Bimzelx), following the approval by the FDA of 2 new device presentations: a 2 mL pre-filled syringe and a pre-filled autoinjector. According to a release from the company, each device contains a 320 mg dose of bimekizumab-bkzx, catering specifically to patients with moderate to severe plaque psoriasis and certain indications of psoriatic arthritis. UCB said this approval represents a pivotal development in the management of these conditions, allowing for more convenient and effective treatment regimens.¹

“Our goal with these single-injection regimens is to strengthen and expand administration options, increase convenience and enhance the individual patient experience,” Emmanuel Caeymaex, executive vice president, head of patient impact, chief commercial officer, UCB, said in the release. “With the new device presentations, people with moderate to severe plaque psoriasis who receive a bimekizumab-bkzx maintenance dose of320 mg will have the option of a single-injection every 8 weeks.”

Device Presentations and Administration

The introduction of these 320 mg single-injection options is a notable enhancement over the previously available 1 mL administration options, which contain 160 mg of bimekizumab-bkzx. By allowing for a single injection every8 weeks, these new devices not only streamline the treatment process but also aim to improve the patient experience.

The company said patients requiring a maintenance dose of 320 mg of bimekizumab-bkzx will benefit significantly from this innovation, as it minimizes the frequency of injections and aligns with modern expectations for therapeutic convenience.

Clinical Evidence Supporting Approval

The FDA's approval of the 320 mg device presentations was substantiated by robust clinical data assessing the bioequivalence of bimekizumab-bkzx administered as a single 2 mL subcutaneous injection versus 2 single mL subcutaneous injections in healthy participants. UCB said this scientific backing not only validates the efficacy of the new delivery system but also supports its anticipated integration into clinical practice.Importantly, this approval follows a similar endorsement from the European Commission in August 2024.²

Indications for Use

In the US, the 320 mg dose of bimekizumab-bkzx is indicated for adults with moderate to severe plaque psoriasis, as well as adults with active psoriatic arthritis who also have moderate to severe plaque psoriasis. For other indications, including adults with active psoriatic arthritis, non-radiographic axial spondyloarthritis with objective signs of inflammation, and ankylosing spondylitis, the company says a 160 mg dose is recommended.

The initial FDA approval for bimekizumab-bkzx in October 2023 focused on moderate to severe plaque psoriasis in adults eligible for systemic therapy or phototherapy. Subsequently, in September 2024, the approval was expanded to include additional indications for psoriatic arthritis and related inflammatory conditions.

Mechanism of Action

Bimekizumab-bkzx is a humanized IgG1 monoclonal antibody that selectively targets and binds to the cytokines IL-17A, IL-17F, and IL-17AF. By blocking their interaction with the IL-17RA/IL-17RC receptor complex, bimekizumab-bkzx addresses the underlying inflammation associated with plaque psoriasis and psoriatic arthritis. UCB noted elevated levels of these cytokines are notably present in lesional psoriatic skin, making this mechanism particularly relevant in the treatment of these conditions.

Conclusion

In the release, UCB said the FDA approval of the 2 mL pre-filled syringe and autoinjector for bimekizumab-bkzx marks a significant advancement in the treatment landscape for moderate to severe plaque psoriasis and psoriatic arthritis. With the introduction of a convenient single-injection regimen, the company aims to enhance patient adherence and overall treatment experience.

References

1. UCB receives US FDA approval for 320 mg single-injection device presentations of BIMZELX[®] (bimekizumab-bkzx). News Release. UCB. Published Octoer 14, 2024. Accessed October 14, 2024. https://www.ucb.com/stories-media/Press-Releases/article/UCB-receives-US-FDA-approval-for-320-mg-single-injection-device-presentations-of-BIMZELXR-bimekizumab-bkzx
2. UCB announces European Commission approval for 320 mg device presentations of BIMZELX[®]▼(bimekizumab). News Release. UCB. Published August 5, 2024. Accessed October 14, 2024. https://www.ucb.com/stories-media/Press-Releases/article/UCB-announces-European-Commission-approval-for-320-mg-device-presentations-of-BIMZELXRVbimekizumab