The U.S. Food and Drug Administration (FDA) has approved a 2mL pre-filled syringe and pre-filled autoinjector pen for 320mg of bimekizumab-bkzx (Bimzelx, UCB).
These new device presentations join the currently available 1mL administration options, each containing 160mg of bimekizumab-bkzx. Patients requiring a 320 mg dose of bimekizumab-bkzx will have options for single-injection administration. They will be available in the U.S. in Q1 2025.
“Our goal with these single-injection regimens is to strengthen and expand administration options, increase convenience and enhance the individual patient experience,” says Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact, and Chief Commercial Officer at UCB, in a news release. “With the new device presentations, people with moderate-to-severe plaque psoriasis who receive a bimekizumab-bkzx maintenance dose of 320mg will have the option of a single-injection every eight weeks.”
The approval of the 320 mg device presentations is supported by data from studies evaluating the bioequivalence of bimekizumab-bkzx 320mg given as one 2mL subcutaneous injection, and bimekizumab-bkzx 32mg given as two 1mL subcutaneous injections, in healthy study participants. This is the second worldwide approval for the 320mg single-injection administration options for bimekizumab-bkzx, following approval by the European Commission in August 2024.
The recommended dosage of bimekizumab-bkzx in patients with plaque psoriasis and patients with psoriatic arthritis with coexistent moderate-to-severe plaque psoriasis is 320mg at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing 120kg or more, consider a dosage of 320mg every 4 weeks after Week 16. In all other indications, adults with active psoriatic arthritis, adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation, and adults with active ankylosing spondylitis, a 160mg dose is recommended.
In October 2023, bimekizumab-bkzx was first approved by the U.S. FDA for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
In September 2024, bimekizumab-bkzx was approved in the U.S. for three new indications – 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.
