UCB Introduces 320 mg/2 mL Single-Injection Option for BIMZELX® in U.S.

UCB, a leading biopharmaceutical firm, has announced the release of a new single-injection device for BIMZELX® (bimekizumab-bkzx) in the United States. This innovative 2 mL prefilled syringe and autoinjector contains 320 mg of the medication, providing a straightforward administration option for patients. This development complements the already available 1 mL devices, each delivering 160 mg of BIMZELX. The introduction of these new devices is expected to enhance the treatment experience for patients requiring a 320 mg dose of BIMZELX through a single injection.

Camille Lee, Head of U.S. Immunology at UCB, highlighted the significance of this advancement. She noted that with the recent FDA approval of five new indications for BIMZELX, the company has been able to address the needs of individuals with chronic inflammatory conditions who have long awaited new treatment options. The single-injection regimen further expands these options, benefiting those with moderate-to-severe plaque psoriasis, active psoriatic arthritis with coexistent moderate-to-severe plaque psoriasis, and moderate-to-severe hidradenitis suppurativa.

The approval for the 320 mg single-injection option was granted in October 2024 and was supported by data demonstrating the bioequivalence of BIMZELX when administered as one 2 mL subcutaneous injection compared to two 1 mL injections. In the U.S., the 320 mg dose is recommended for adults with moderate-to-severe plaque psoriasis, adults with active psoriatic arthritis and coexistent moderate-to-severe plaque psoriasis, and adults with moderate-to-severe hidradenitis suppurativa. For other indications, such as active psoriatic arthritis, non-radiographic axial spondyloarthritis with signs of inflammation, and active ankylosing spondylitis, a 160 mg dose is advised.

BIMZELX is a humanized monoclonal IgG1 antibody designed to inhibit interleukin 17A (IL-17A) and interleukin 17F (IL-17F), both of which are instrumental in driving inflammatory processes. The drug is approved for several conditions, including moderate-to-severe plaque psoriasis, active psoriatic arthritis, non-radiographic axial spondyloarthritis, ankylosing spondylitis, and moderate-to-severe hidradenitis suppurativa.

UCB’s BIMZELX Navigate® program offers personalized support to patients prescribed BIMZELX. Upon enrollment, patients receive assistance from a dedicated Nurse Navigator, a licensed nurse who helps with treatment goals, administration training, copay support, and updates on shipments and insurance coverage.

The company is also actively involved in discussions with payers to ensure access to their medications under a sustainable model that benefits patients, society, and UCB. Through these initiatives, UCB aims to make BIMZELX accessible to those in need while maintaining affordability.

In terms of safety, BIMZELX may increase the risk of suicidal ideation and behavior, and potential risks should be carefully considered by prescribers. The medication also carries a risk of infections, and patients should be monitored for signs of serious infections. Additionally, patients should be evaluated for tuberculosis before starting treatment, and liver enzyme levels should be checked regularly due to the risk of liver biochemical abnormalities.

Overall, the introduction of the single-injection device for BIMZELX represents a significant advancement in the treatment of chronic inflammatory conditions, offering patients a more convenient option and enhancing their quality of care.