UCB Launches 320mg Single-Injection Bimekizumab

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UCB announced today in a news release the introduction of a new single-injection 2 mL prefilled syringe and autoinjector, each containing 320 mg of bimekizumab (Bimzelx). These newly available devices complement the existing 1 mL administration options, which each contain 160 mg of the medication. This development is expected to enhance the convenience of bimekizumab administration for patients requiring a 320 mg dose.¹

In the release, Camille Lee, head of US immunology at UCB, highlighted the significance of this advancement, stating, “With 5 new FDA-approved indications for [bimekizumab] in just over a year, we’ve had the opportunity to reach a wider range of people living with chronic inflammatory conditions who have long been in need of new treatment options. With the addition of a single-injection administration regimen, we are further expanding options and enhancing the treatment experience for individuals with moderate to severe plaque psoriasis, active psoriatic arthritis (PsA) with coexistent moderate to severe plaque psoriasis, and moderate to severe hidradenitis suppurativa (HS) who receive a320 mg dose of [bimekizumab].”

The FDA approved the 320 mg single-injection option in October 2024. This approval followed data from clinical studies demonstrating the bioequivalence of bimekizumab 320 mg administered as a single 2 mL subcutaneous injection versus 2 1 mL subcutaneous injections.² “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 October 2024 release. “With the new device presentations, people with moderate to severe plaque psoriasis who receive a bimekizumab-bkzx maintenance dose of 320 mg will have the option of a single-injection every 8 weeks.”

The recommended indications for the 320 mg dose include:

• Moderate to severe plaque psoriasis
• Active PsA with coexistent moderate to severe plaque psoriasis
• Moderate to severe HS

For other indications, including active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation and active ankylosing spondylitis (AS), a 160 mg dose is recommended. The company stated bimekizumab’s broad range of indications and tailored dosing regimens provide treatment options for diverse patient needs. 

According to the release, bimekizumab is a humanized monoclonal IgG1 antibody designed to selectively inhibit interleukin 17A and interleukin 17F, cytokines that play a key role in inflammatory processes. By targeting these cytokines, the drug addresses chronic inflammation and tissue damage associated with conditions like plaque psoriasis, PsA, nr-axSpA, AS, and HS.

Bimekizumab is approved for the following indications:

• Plaque Psoriasis: Treatment of moderate to severe plaque psoriasis in adults eligible for systemic therapy or phototherapy. Recommended dosage is 320 mg subcutaneously at weeks 0, 4, 8, 12, and 16, followed by maintenance doses every 8 weeks. For patients over 120 kg, consider a320 mg dose every 4 weeks after week 16.
• PsA: Treatment of adults with active PsA. Recommended dosage is 160 mg subcutaneously every 4 weeks. For coexisting moderate to severe plaque psoriasis, follow the plaque psoriasis dosing regimen.
• nr-axSpA: Treatment of adults with active nr-axSpA with objective signs of inflammation. Recommended dosage is 160 mg subcutaneously every 4 weeks.
• AS: Treatment of adults with active AS. Recommended dosage is 160 mg subcutaneously every 4 weeks.
• HS: Treatment of adults with moderate to severe HS. Recommended dosage is 320 mg subcutaneously at weeks 0, 2, 4, 6, 8, 10, 12, 14, and 16, then every 4 weeks. 

This new dosing option exemplifies UCB’s commitment to innovation and patient-centered care, addressing the evolving needs of individuals with chronic inflammatory diseases.

References

1. UCB announces US availability of 320 mg/2 mL single-injection administration option for BIMZELX® (bimekizumab-bkzx). News Release. PR Newswire. Published January 16, 2025. Accessed January 16, 2025. https://www.prnewswire.com/news-releases/ucb-announces-us-availability-of-320-mg2-ml-single-injection-administration-option-for-bimzelx-bimekizumab-bkzx-302352452.html
2. UCB receives US FDA approval for 320 mg single-injection device presentations of BIMZELX[®] (bimekizumab-bkzx). News Release. UCB. Published October 14, 2024. Accessed January 16, 2025. 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