UCB Announces U.S. Availability of 320 mg/2 mL Single-Injection Administration Option for BIMZELX® (bimekizumab-bkzx)
UCB has announced the U.S. commercial availability of a new single-injection 320 mg/2 mL administration option for BIMZELX® (bimekizumab-bkzx). The new presentation includes a prefilled syringe and autoinjector, complementing the existing 160 mg/1 mL devices.
This development follows the October 2024 approval, supported by bioequivalence studies comparing single 2 mL versus two 1 mL injections. The 320 mg dose is recommended for adults with moderate-to-severe plaque psoriasis, active psoriatic arthritis with coexistent moderate-to-severe plaque psoriasis, and moderate-to-severe hidradenitis suppurativa. A 160 mg dose remains recommended for other indications.
UCB offers patient support through BIMZELX Navigate®, providing dedicated Nurse Navigators, administration training, and copay support for eligible patients.
UCB ha annunciato la disponibilità commerciale negli Stati Uniti di una nuova opzione di somministrazione con un'unica iniezione da 320 mg/2 mL per il BIMZELX® (bimekizumab-bkzx). La nuova presentazione include una siringa pre-riempita e un autoiniettore, a complemento dei dispositivi esistenti da 160 mg/1 mL.
Questo sviluppo segue l'approvazione di ottobre 2024, supportata da studi di bioequivalenza che confrontano una singola iniezione da 2 mL con due iniezioni da 1 mL. La dose da 320 mg è raccomandata per adulti con psoriasi a placche da moderata a grave, artrite psoriasica attiva con psoriasi a placche da moderata a grave coesistente, e hidradenite supprativa da moderata a grave. La dose da 160 mg rimane raccomandata per altre indicazioni.
UCB offre supporto ai pazienti attraverso BIMZELX Navigate®, che fornisce Infermieri Navigatori dedicati, formazione per la somministrazione e supporto per i co-pagamenti per i pazienti idonei.
UCB ha anunciado la disponibilidad comercial en EE.UU. de una nueva opción de administración de 320 mg/2 mL con una sola inyección para el BIMZELX® (bimekizumab-bkzx). La nueva presentación incluye una jeringa precargada y un autoinyector, complementando los dispositivos existentes de 160 mg/1 mL.
Este desarrollo sigue a la aprobación en octubre de 2024, respaldada por estudios de bioequivalencia que comparan una única inyección de 2 mL con dos inyecciones de 1 mL. La dosis de 320 mg se recomienda para adultos con psoriasis en placas de moderada a grave, artritis psoriásica activa con psoriasis en placas de moderada a grave coexistente, y hidradenitis supurativa de moderada a grave. La dosis de 160 mg sigue siendo recomendada para otras indicaciones.
UCB ofrece apoyo a los pacientes a través de BIMZELX Navigate®, proporcionando Navegadores de Enfermería dedicados, capacitación en la administración y apoyo para copagos a pacientes elegibles.
UCB는 미국에서 BIMZELX® (bimekizumab-bkzx)의 새로운 단일 주사 320 mg/2 mL 투여 옵션의 상업적 이용 가능성을 발표했습니다. 새로운 형태는 미리 채워진 주사기와 자동 주사기를 포함하여 기존의 160 mg/1 mL 장치를 보완합니다.
이 개발은 2024년 10월 승인을 따르며, 2 mL 단일 주사와 1 mL 두 번 주사를 비교하는 생물학적 동등성 연구에 의해 지원됩니다. 320 mg 용량은 중등도에서 중증의 판상 건선, 동반된 중등도에서 중증의 판상 건선이 있는 활동성 건선 관절염 및 중등도에서 중증의 농피증을 가진 성인에게 권장됩니다. 160 mg 용량은 다른 적응증에 대해 여전히 권장됩니다.
UCB는 BIMZELX Navigate®를 통해 환자 지원을 제공하며, 전담 간호사 내비게이터, 투여 교육 및 적격 환자를 위한 공동 지불 지원을 제공합니다.
UCB a annoncé la disponibilité commerciale aux États-Unis d'une nouvelle option d'administration par injection unique de 320 mg/2 mL pour le BIMZELX® (bimekizumab-bkzx). La nouvelle présentation comprend une seringue préremplie et un auto-injecteur, complétant les dispositifs existants de 160 mg/1 mL.
Ce développement fait suite à l'approbation d'octobre 2024, soutenue par des études de bioéquivalence comparant une injection de 2 mL à deux injections de 1 mL. La dose de 320 mg est recommandée pour les adultes atteints de psoriasis en plaques modéré à sévère, d'arthrite psoriasique active avec psoriasis en plaques modéré à sévère coexistante, et d'hydradénite suppurative modérée à sévère. Une dose de 160 mg reste recommandée pour d'autres indications.
UCB offre un soutien aux patients via BIMZELX Navigate®, en fournissant des Navigateurs Infirmiers dédiés, une formation à l'administration et un soutien pour les co-paiements pour les patients éligibles.
UCB hat die kommerzielle Verfügbarkeit einer neuen Einmalinjektionsoption von 320 mg/2 mL für BIMZELX® (bimekizumab-bkzx) in den USA bekannt gegeben. Die neue Präsentation umfasst eine vorgefüllte Spritze und einen Autoinjektor und ergänzt die bestehenden Geräte mit 160 mg/1 mL.
Diese Entwicklung folgt auf die Genehmigung im Oktober 2024, die durch bioäquivalenzstudien unterstützt wurde, die eine einzelne Injektion von 2 mL mit zwei Injektionen von 1 mL vergleichen. Die Dosis von 320 mg wird für Erwachsene mit moderater bis schwerer Plaque-Psoriasis, aktiver psoriatischer Arthritis mit begleitender moderater bis schwerer Plaque-Psoriasis, und moderater bis schwerer Hidradenitis suppurativa empfohlen. Die Dosis von 160 mg bleibt für andere Indikationen empfohlen.
UCB bietet Patientensupport über BIMZELX Navigate® an, indem es engagierte Pflege-Navigatoren, Ausbildung zur Verabreichung und Co-Payment-Unterstützung für berechtigte Patienten bereitstellt.
- Launch of more convenient single-injection 320 mg administration option
- Five FDA-approved indications secured in just over a year
- Expanded treatment options for multiple inflammatory conditions
- None.
- BIMZELX® (bimekizumab-bkzx) is now commercially available by prescription in
the United States in a 2 mL prefilled syringe and autoinjector, each containing 320 mg of BIMZELX - The single-injection device offers convenience for patients requiring a 320 mg dose of BIMZELX with single-injection administration
With the new presentations, patients requiring a 320 mg dose of BIMZELX will have options for single-injection administration.1
"With five new FDA-approved indications for BIMZELX in just over a year, we've had the opportunity to reach a wider range of people living with chronic inflammatory conditions who have long been in need of new treatment options," said Camille Lee, Head of
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.1 In the
Through BIMZELX Navigate®, UCB offers tailored patient support to patients who have been prescribed BIMZELX. Upon enrollment, 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. Patients who have been prescribed BIMZELX 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.
Notes to Editors:
About BIMZELX® (bimekizumab-bkzx)
BIMZELX is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes.1 IL-17A and IL-17F are key contributors of chronic inflammation and damage across multiple tissues, with IL-17F increasing over time.1, 2-4 IL-17F is over-expressed in skin and highly elevated in the serum of patients with PSO, PsA, nr-axSpA, AS, and HS.1, 2-5
The approved indications for BIMZELX in the
- Plaque psoriasis: BIMZELX is approved for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
- Psoriatic arthritis: BIMZELX is indicated for the treatment of adult patients with active psoriatic arthritis
- Non-radiographic axial spondyloarthritis: BIMZELX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation
- Ankylosing spondylitis: BIMZELX is indicated for the treatment of adult patients with active ankylosing spondylitis
- Hidradenitis suppurativa: BIMZELX is indicated for the treatment of adult patients with moderate-to-severe hidradenitis suppurativa
*The recommended dosage of BIMZELX in patients is as follows:
- Plaque Psoriasis: Administer 320 mg by subcutaneous injection at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing 120 kg or more, consider a dose of 320 mg every 4 weeks after Week 16.
- Psoriatic Arthritis: Administer 160 mg by subcutaneous injection every 4 weeks. For patients with coexisting moderate-to-severe plaque psoriasis, use the dosage and administration for plaque psoriasis.
- Non-Radiographic Axial Spondyloarthritis: Administer 160 mg by subcutaneous injection every 4 weeks.
- Ankylosing Spondylitis: Administer 160 mg by subcutaneous injection every 4 weeks.
- Hidradenitis Suppurativa: Administer 320 mg by subcutaneous injection at Weeks 0, 2, 4, 6, 8, 10, 12, 14 and 16, then every 4 weeks thereafter.
See full prescribing information for recommendations regarding missed doses, preparation and administration instructions.
Please see Important Safety Information below and full
BIMZELX
IMPORTANT SAFETY INFORMATION
Suicidal Ideation and Behavior
BIMZELX (bimekizumab-bkzx) may increase the risk of suicidal ideation and behavior (SI/B). A causal association between treatment with BIMZELX and increased risk of SI/B has not been definitively established. Prescribers should weigh the potential risks and benefits before using BIMZELX in patients with a history of severe depression or SI/B. Advise monitoring for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, instruct to promptly seek medical attention, refer to a mental health professional as appropriate, and re-evaluate the risks and benefits of continuing treatment.
Infections
BIMZELX may increase the risk of infections, including serious infections. Do not initiate treatment with BIMZELX in patients with any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing BIMZELX. Instruct patients to seek medical advice if signs or symptoms suggestive of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and do not administer BIMZELX until the infection resolves.
Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX. Avoid the use of BIMZELX in patients with active TB infection. Initiate treatment of latent TB prior to administering BIMZELX. Consider anti-TB therapy prior to initiation of BIMZELX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor patients for signs and symptoms of active TB during and after treatment.
Liver Biochemical Abnormalities
Elevated serum transaminases were reported in clinical trials with BIMZELX. Test liver enzymes, alkaline phosphatase, and bilirubin at baseline, periodically during treatment with BIMZELX, and according to routine patient management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt BIMZELX until a diagnosis of liver injury is excluded. Permanently discontinue use of BIMZELX in patients with causally associated combined elevations of transaminases and bilirubin. Avoid use of BIMZELX in patients with acute liver disease or cirrhosis.
Inflammatory Bowel Disease
Cases of inflammatory bowel disease (IBD) have been reported in patients treated with IL-17 inhibitors, including BIMZELX. Avoid use of BIMZELX in patients with active IBD. During BIMZELX treatment, monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs.
Immunizations
Prior to initiating therapy with BIMZELX, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with BIMZELX.
Most Common Adverse Reactions
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For further information, contact UCB:
Investor Relations
Antje Witte
T +32.2.559.94.14
email antje.witte@ucb.com
Brand Communications
Nicole Herga
T +1.773.960.5349
email nicole.herga@ucb.com
About UCB
UCB,
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References
- BIMZELX® (bimekizumab-bkzx)
U.S. Prescribing Information. https://www.ucb-usa.com/Innovation/Products/BIMZELX. Accessed January 2025. - Glatt S, Baeten D, Baker T et al. Dual IL-17A and IL-17F neutralisation by bimekizumab in psoriatic arthritis: evidence from preclinical experiments and a randomised placebo-controlled clinical trial that IL-17F contributes to human chronic tissue inflammation. Ann Rheum Dis. 2018;77:523–32.
- Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety in moderate-to-severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021;397(10273):475-486.
- Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for the treatment of moderate-to-severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial. Lancet. 2021;397(10273):487-498.
- Rumberger BE, Boarder EL, Owens SL, et al. Transcriptomic analysis of hidradenitis suppurativa skin suggests roles for multiple inflammatory pathways in disease pathogenesis. Inflamm Res. 2020;69(10):967-973.
US-BK-2401977
Date of preparation: January 2025
BIMZELX®, UCBCares®, and BIMZELX Navigate® are registered trademarks of the UCB Group of Companies.
©2025 UCB, Inc.,
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