Single-injection 2mL prefilled syringes and autoinjectors containing 320mg of bimekizumab-bkzx (Bimzelx, UCB) are now commercially available, UCB reports.
These are in addition to the currently available 1mL devices, each containing 160mg of bimekizumab-bkzx. With the new presentations, patients requiring a 320mg dose of bimekizumab-bkzx will have options for single-injection administration.
The approval of the 320mg single-injection administration option in October 2024 was supported by data from studies evaluating the bioequivalence of bimekizumab-bkzx 320mg given as one 2mL subcutaneous injection, and bimekizumab-bkzx 320mg given as two 1mL subcutaneous injections, in healthy study participants.
In the U.S., the indications for bimekizumab-bkzx where a 320mg dose is recommended are adults with moderate-to-severe plaque psoriasis, adults with active psoriatic arthritis (PsA) with coexistent moderate-to-severe plaque psoriasis, and adults with moderate-to-severe hidradenitis suppurativa (HS).
In all other indications, adults with active PsA, adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and adults with active ankylosing spondylitis (AS), a 160mg dose is recommended.
Access Update
Through BIMZELX Navigate, UCB offers tailored patient support to patients who have been prescribed bimekizumab-bkzx. Upon enrollment, patients will be offered support from a dedicated Nurse Navigator. This nurse will be available to discuss treatment goals, provide training assistance to patients on how to administer bimekizumab-bkzx, connect eligible patients to copay support, and keep patients up to date about their bimekizumab-bkzx shipment and insurance coverage status. Patients who have been prescribed bimekizumab-bkzx may enroll in BIMZELX Navigate at https://www.bimzelx.com/patient-support.
UCB is actively engaging in access conversations with payers, with a focus on our patient value strategy and keeping the patient at the center of these discussions. Based on these conversations, we are progressing well toward our goal to enable access to our medicines for people who need them, in a way that is sustainable for patients, society, and UCB. Full affordability information can be found at ucb-usa.com/Sustainability/Affordability/Bimzelx-Pricing-Info and http://www.BIMZELX.com. For additional medical information, patient assistance or any other information, please call UCBCares® at 1-844-599-CARE (2273) or visit askucbcares.com.
