UCB Receives U.S. FDA Approval for BIMZELX® (bimekizumab-bkzx) as the First IL-17A and IL-17F Inhibitor for Adults with Moderate-to-Severe Hidradenitis Suppurativa
UCB has received FDA approval for BIMZELX (bimekizumab-bkzx) to treat adults with moderate-to-severe hidradenitis suppurativa (HS). This marks the fifth indication for BIMZELX in the U.S. and makes it the first IL-17A and IL-17F inhibitor approved for HS treatment. The approval is based on two Phase 3 studies, BE HEARD I and BE HEARD II, which demonstrated improved disease signs and symptoms versus placebo at Week 16, sustained through Week 48. HS is a chronic, painful inflammatory skin disease affecting approximately 1 in 100 people. The drug previously received FDA approvals for psoriatic arthritis, non-radiographic axial spondyloarthritis, ankylosing spondylitis, and plaque psoriasis.
UCB ha ricevuto l'approvazione della FDA per BIMZELX (bimekizumab-bkzx) per trattare gli adulti con hidradenitis suppurativa (HS) da moderata a grave. Questo rappresenta la quinta indicazione per BIMZELX negli Stati Uniti ed è il primo inibitore di IL-17A e IL-17F approvato per il trattamento della HS. L'approvazione si basa su due studi di Fase 3, BE HEARD I e BE HEARD II, che hanno dimostrato un miglioramento dei segni e dei sintomi della malattia rispetto al placebo alla Settimana 16, mantenuto fino alla Settimana 48. L'HS è una malattia della pelle infiammatoria cronica e dolorosa che colpisce circa 1 persona su 100. Il farmaco ha precedentemente ricevuto approvazioni dalla FDA per l'artrite psoriasica, la spondiloartrite assiale non radiografica, la spondilite anchilosante e la psoriasi a placche.
UCB ha recibido la aprobación de la FDA para BIMZELX (bimekizumab-bkzx) para tratar a adultos con hidradenitis supurativa (HS) de moderada a severa. Esta es la quinta indicación para BIMZELX en los EE. UU. y lo convierte en el primer inhibidor de IL-17A y IL-17F aprobado para el tratamiento de la HS. La aprobación se basa en dos estudios de Fase 3, BE HEARD I y BE HEARD II, que demostraron una mejoría en los signos y síntomas de la enfermedad en comparación con el placebo a la Semana 16, sostenido hasta la Semana 48. La HS es una enfermedad cutánea inflamatoria crónica y dolorosa que afecta aproximadamente a 1 de cada 100 personas. El medicamento recibió previamente aprobaciones de la FDA para la artritis psoriásica, la espondiloartritis axial no radiográfica, la espondilitis anquilosante y la psoriasis en placas.
UCB는 중등도에서 중증의 함입성 염증 병변(hidradenitis suppurativa, HS)을 치료하기 위해 BIMZELX (bimekizumab-bkzx)에 대한 FDA 승인을 받았습니다. 이는 미국에서 BIMZELX의 다섯 번째 적응증이며, HS 치료를 위해 승인된 최초의 IL-17A 및 IL-17F 억제제입니다. 이 승인은 3상 연구인 BE HEARD I 및 BE HEARD II에 기반하며, 이는 16주 차에 플라세보와 비교해 질병의 징후와 증상이 개선되었음을 보여주며, 48주까지 지속되었습니다. HS는 약 100명 중 1명에 영향을 미치는 만성적이고 고통스러운 염증성 피부 질환입니다. 이 약물은 이전에 건선성 관절염, 비방사선 축 요소 척추염, 강직성 척추염 및 판상 건선에 대한 FDA 승인을 받았습니다.
UCB a reçu l'approbation de la FDA pour BIMZELX (bimekizumab-bkzx) afin de traiter les adultes atteints d'hydradénite suppurative (HS) de modéré à sévère. Cela marque la cinquième indication pour BIMZELX aux États-Unis et en fait le premier inhibiteur IL-17A et IL-17F approuvé pour le traitement de la HS. L'approbation repose sur deux études de Phase 3, BE HEARD I et BE HEARD II, qui ont démontré une amélioration des signes et des symptômes de la maladie par rapport au placebo à la semaine 16, maintenue jusqu'à la semaine 48. La HS est une maladie inflammatoire de la peau chronique et douloureuse qui affecte environ 1 personne sur 100. Le médicament a précédemment reçu des approbations de la FDA pour l'arthrite psoriasique, la spondylarthrite axiale non radiographique, la spondylarthrite ankylosante et le psoriasis en plaques.
UCB hat die FDA-Zulassung für BIMZELX (bimekizumab-bkzx) zur Behandlung von Erwachsenen mit moderater bis schwerer hidradenitis suppurativa (HS) erhalten. Dies ist die fünfte Indikation für BIMZELX in den USA und macht es zum ersten zugelassenen IL-17A- und IL-17F-Hemmer für die Behandlung von HS. Die Zulassung basiert auf zwei Phase-3-Studien, BE HEARD I und BE HEARD II, die eine Verbesserung der Krankheitszeichen und -symptome im Vergleich zu Placebo in der Woche 16 und bis zur Woche 48 zeigten. HS ist eine chronische, schmerzhafte entzündliche Hauterkrankung, die etwa 1 von 100 Menschen betrifft. Das Medikament erhielt zuvor FDA-Zulassungen für psoriatische Arthritis, nicht-radiografische axiale Spondyloarthritis, ankylosierende Spondylitis und Plaque-Psoriasis.
- First and only approved IL-17A and IL-17F inhibitor for HS treatment
- Demonstrated superior efficacy vs placebo in Phase 3 trials
- Sustained clinical responses up to 48 weeks
- Expands market reach with fifth FDA-approved indication
- Safety profile consistent with previous trials
- None.
- Approval is supported by data from the two Phase 3 studies, BE HEARD I and BE HEARD II, in which BIMZELX® (bimekizumab-bkzx) improved the signs and symptoms of disease vs. placebo at Week 16, which were sustained to Week 48
- Hidradenitis suppurativa is a chronic, painful, and potentially debilitating inflammatory skin disease
- The milestone marks the fifth indication for BIMZELX in the
U.S. , underscoring UCB's commitment to raising standards of care across a range of IL-17 mediated diseases
"The approval of BIMZELX in moderate-to-severe hidradenitis suppurativa is welcome given the substantial unmet clinical needs and limited number of treatment options available today," said investigator and lead author of the studies, Alexa B. Kimball, MD, MPH, Beth Israel Deaconess Medical Center and Professor of Dermatology, Harvard Medical School,
Hidradenitis suppurativa is a chronic, recurring, painful, and potentially debilitating inflammatory skin disease.2-3 The main symptoms are nodules, abscesses, and pus-discharging fistulas, i.e., channels leading out of the skin, typically in the armpits, groin, and buttocks.2-3 People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life.2-3
"We are working toward a world where people with hidradenitis suppurativa live without stigma, feel widely understood, and are treated effectively. Today's approval of bimekizumab-bkzx is an exciting time for the hidradenitis suppurativa community, offering a new possibility for the treatment of people in the
The approval is supported by data from two Phase 3 studies, BE HEARD I and BE HEARD II, which evaluated the efficacy and safety of BIMZELX in the treatment of adults with moderate-to-severe HS.4 Results showed that a higher proportion of patients treated with BIMZELX vs. placebo achieved a 50 percent or greater improvement in HS signs and symptoms at Week 16, as measured by HiSCR50, the primary endpoint in both trials.4 BIMZELX treatment also resulted in clinically meaningful improvements in the key ranked secondary endpoint, HiSCR75, vs. placebo at Week 16.4 Clinical responses were sustained to Week 48.4 The safety profile of BIMZELX was consistent with safety data seen in previous trials across indications with no new safety signals.4 Detailed results from BE HEARD I and BE HEARD II have been published in The Lancet.4
"We are thrilled that with this milestone BIMZELX is now FDA-approved for the treatment of adults with moderate-to-severe hidradenitis suppurativa, a chronic and painful disease affecting approximately one in 100 people. This is the fifth patient population who may benefit from BIMZELX in the
This FDA approval of BIMZELX for the treatment of adults with moderate-to-severe hidradenitis suppurativa follows its recent approvals for 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.1 BIMZELX was first approved in the
Additional information about BIMZELX, including the full prescribing information, is available at UCB-USA.com/Innovation/Products/BIMZELX. For additional medical information, patient assistance or any other information, please call UCBCares® at 1-844-599-CARE (2273) or visit askucbcares.com. UCB's goal is to enable affordable access to our medicines for all people who need them, in a way which is sustainable for patients, society and UCB. Full affordability information can be found at UCB-USA.com/Affordability and www.BIMZELX.com.
Notes to Editors:
About Hidradenitis Suppurativa
Hidradenitis suppurativa (HS) is a chronic, painful, and potentially debilitating inflammatory skin disease that is associated with systemic manifestations.2-3 The main symptoms are nodules, abscesses, and pus-discharging draining tunnels (or sinus tracts leading out of the skin) that typically occur in the armpits, groin, and buttocks.2-3 People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life.2-3 HS develops in early adulthood and affects approximately one percent of the population in most studied countries.2-3
About BE HEARD I and BE HEARD II
BE HEARD I and BE HEARD II are randomized, double-blind, placebo-controlled, parallel group, multicenter, Phase 3 studies designed to evaluate the efficacy and safety of BIMZELX in adults with moderate-to-severe hidradenitis suppurativa (HS).4 The two studies had a combined enrollment of 1,014 participants with a diagnosis of moderate-to-severe HS.4 The primary endpoint in both studies was HiSCR50 at Week 16.4 Secondary endpoints included HiSCR75 and HS-specific skin pain response at Week 16.1,4 HiSCR50 and HiSCR75 are defined as at least either a 50 or 75 percent reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.4 Detailed results from these studies are published in The Lancet.4
About BIMZELX® (bimekizumab-bkzx) in the
BIMZELX is a humanized IgG1 monoclonal antibody that selectively binds to IL-17A, IL-17F and IL-17AF cytokines, blocking their interaction with the IL-17RA/IL-17RC receptor complex.1
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
Please see Important Safety Information below and full
BIMZELX
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: November 2024. - Jemec GB. Clinical practice: hidradenitis suppurativa. N Engl J Med. 2012;366(2):158-64.
- Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. Nat Rev Dis Primers. 2020;6(1):18.
- Kimball AB, Jemec GBE, Sayed CJ, et al. Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 48 week, randomised, double blind, placebo controlled, multicentre phase 3 trials. Lancet. 2024;403(10443):2504-19.
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