UCB Secures FDA Approval for 320 mg Single-injection BIMZELX® Device
Monday, October 14, 2024
UCB has received approval from the U.S. Food and Drug Administration (FDA) for new 2 mL pre-filled syringe and pre-filled autoinjector options, each containing 320 mg of BIMZELX® (bimekizumab-bkzx).
Bimekizumab-bkzx is a humanized monoclonal antibody that targets the IL-17A, IL-17F, and IL-17AF cytokines, known to play a key role in conditions like plaque psoriasis by interacting with the IL-17 receptor complex.
These new presentations complement the existing 1 mL options, which contain 160 mg of bimekizumab-bkzx. The updated device presentations offer patients requiring a 320 mg dose the convenience of a single injection.
This approval is based on bioequivalence data from studies comparing the administration of bimekizumab-bkzx as a single 2 mL injection to two separate 1 mL injections. The 320 mg device option was first approved by the European Commission in August 2024.
In the U.S., bimekizumab-bkzx is recommended for adults with moderate-to-severe plaque psoriasis or adults with active psoriatic arthritis combined with moderate-to-severe plaque psoriasis.
For other conditions such as active psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis, a 160 mg dose is advised.
The drug was initially approved in the U.S. in October 2023 for treating moderate-to-severe plaque psoriasis, with three additional indications approved in September 2024.
The new 320 mg single-injection device presentations are expected to be available in the U.S. by the first quarter of 2025.
Source: ucb.com
