FDA Approves Single-Dose Regimen of UCB’s Bimzelx for Moderate-to-Severe Plaque Psoriasis, Active Psoriatic Arthritis

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The FDA has approved an expanded indication for UCB’s new 320 mg single-injection device presentation of Bimzelx (bimekizumab) for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis. According to the company, the prefilled syringe and autoinjector options allow for a single 2 mL subcutaneous injection, as opposed to the previous regimen of two 1 mL injections. The new indication offers a more convenient administration option for patients with moderate-to-severe plaque psoriasis and active psoriatic arthritis.¹

“Our goal with these single-injection regimens is to strengthen and expand administration options, increase convenience, and enhance the individual patient experience,” said Emmanuel Caeymaex, EVP, head, patient impact, chief commercial officer, UCB, in a press 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 eight weeks.”

Bimzelx, a humanized monoclonal IgG1 antibody, was developed to selectively inhibit IL-17A and IL-17F. The drug 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 IL-17F inhibitor.

UCB stated that the new formulation aims to enhance the patient experience by simplifying dosing for those on a maintenance regimen of 320 mg every eight weeks. This indication follows data demonstrating bioequivalence between the single-injection and two-injection methods.¹

According to the National Psoriasis Foundation, over eight million people in the United States are currently living with psoriasis. Globally, around 125 million people have psoriasis, which equals 2% or 3% of the entire population. Thirty percent of people with psoriasis will develop psoriatic arthritis later in life. Onset of psoriasis is most common between 20 and 30 years of age and again between 50 and 60 years of age; however, it can develop at any age.

Psoriasis results in annual health care costs of around $135 billion. In the United States, the disease burden is substantial due to considerable negative physical, psychiatric, and social consequences.²

The new option of Bimzelx is expected to be available in the first quarter of next year. Last month, it was approved for the treatment of adults with active psoriatic arthritis, adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation, and adults with active ankylosing spondylitis.¹

References

1. UCB Receives U.S. FDA Approval for 320 mg Single-Injection Device Presentations of BIMZELX® (bimekizumab-bkzx). UCB. October 14, 2024. Accessed October 14, 2024. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/ucb-receives-us-fda-approval-for-320-mg-single-injection-device-presentations-of-bimzelx-bimekizumab-bkzx

2. Psoriasis Statistics. NPF. Accessed October 14, 2024. https://www.psoriasis.org/psoriasis-statistics/