Biopharmaceutical company UCB (Euronext Brussels:UCB) announced on Thursday that it has launched a single-injection 2 mL prefilled syringe and autoinjector, each containing 320 mg of BIMZELX (bimekizumab-bkzx).
This is in addition to the currently available 1 ml device administration option, each containing 160 mg of the product. With the new device, patients requiring a 320 mg dose of BIMZELX will have the option of single-injection administration.
The approval of the 320 mg single-injection administration option in October 2024 was supported by data from studies evaluating the bioequivalence of BIMZELX 320 mg given as one 2 mL subcutaneous injection, and BIMZELX 320 mg given as two 1 mL subcutaneous injections, in healthy study participants.
Through BIMZELX Navigate, UCB offers tailored patient support to patients who have been prescribed BIMZELX. Upon enrolment, patients will be offered support from a dedicated Nurse Navigator. This licensed, registered nurse will be available to discuss treatment goals, provide training assistance to patients on how to administer BIMZELX, connect eligible patients to copay support, and keep patients up-to-date about their BIMZELX shipment and insurance coverage status.
Vast Therapeutics' ALX1 drug candidate granted QIDP designation by US FDA
Qlife secures UK approval to initiate clinical trial for Egoo Phe System
Healthcare Holding Schweiz AG acquires Effectum CH-Rep AG to expand services
Femasys receives CE mark approval for FemBloc delivery system in Europe
Avance Biosciences registers with CLIA program
Abbott announces quarterly common dividend
Aiforia secures IVDR certification for expanded AI-powered cancer diagnostics in Europe
Limaca Medical launches Precision-GI endoscopic automated motorised EUS biopsy device in US
Owens & Minor launches ByramConnect digital health platform for diabetes management
Acrivon Therapeutics receives FDA Breakthrough Device designation for ACR-368 OncoSignature assay
BrainCool secures market approval for BrainCool System in Malaysia
Bioretec Ltd secures CE mark approval for RemeOs Trauma Screw portfolio
Biohit launches FAEX Sample System for stool sample collection
Renalys Pharma completes patient enrolment for Phase III clinical trial of sparsentan