- Marketing authorization in the European Union (EU) represents the first regulatory approval worldwide for bimekizumab in the treatment of moderate to severe hidradenitis suppurativa, and its fourth approved indication within the EU
- Approval is supported by data from two Phase 3 studies, BE HEARD I and BE HEARD II, in which bimekizumab significantly improved the signs of disease compared with placebo at Week 16, which were sustained to Week 48, and was well-tolerated
- Hidradenitis suppurativa is a chronic, relapsing and painful inflammatory skin disease with a significant unmet clinical need for which there are few approved treatment options
BRUSSELS, Belgium I April 22, 2024 I UCB, a global biopharmaceutical company, today announced that the European Commission (EC) has granted marketing authorization for BIMZELX® (bimekizumab) for the treatment of active moderate to severe hidradenitis suppurativa (HS) in adults with an inadequate response to conventional systemic HS therapy.1 The approval follows a positive opinion issued in March 2024 by the Committee for Medicinal Products for Human Use of the European Medicines Agency. The EC approval was granted based on results from two Phase 3 studies, BE HEARD I and BE HEARD II, which evaluated the efficacy and safety of bimekizumab in the treatment of moderate to severe HS.
“The European Commission’s approval of bimekizumab marks a significant milestone for the EU hidradenitis suppurativa community, particularly considering the limited treatment options currently available,” said Prof. Dr. Christos C. Zouboulis, President of the European Hidradenitis Suppurativa Foundation (EHSF) e.V. and Director of the Departments of Dermatology, Venereology, Allergology and Immunology, Städtisches Klinikum Dessau, Brandenburg Medical School, Germany. “As a community, we strive to improve the management of hidradenitis suppurativa. Bimekizumab offers a promising new therapeutic option for moderate to severe disease, supported by Phase 3 evidence that demonstrated clinically meaningful and sustained responses over 48 weeks.”
HS is a chronic, relapsing inflammatory skin disease that manifests as nodules, abscesses and pus-discharging fistulas, i.e., channels leading out of the skin, typically in the armpits, groin, and buttocks.2,3 HS typically starts in early adulthood and affects approximately one percent of the population in most studied countries.2,3 HS is associated with significant co-morbidities and can have a profound negative effect on patients’ quality of life.2,3
“Hidradenitis suppurativa can have a devastating impact on people, especially those with moderate to severe disease. In addition to the physical symptoms, there can also be a considerable psychological burden for many people, resulting in a reduced quality of life and missing out on important life events,” said Barry McGrath, Ph.D., Co-Founder of HS Ireland, an association for all people affected by hidradenitis suppurativa in Ireland. “The possibility of a new treatment option to help people living with this disease is most welcome.”
“We are proud to bring the first and only approved medicine targeting IL-17A and IL-17F to the hidradenitis suppurativa community. We believe that bimekizumab has the potential to transform care for people living with moderate to severe disease,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S. “Today’s approval signifies the expansion of bimekizumab to its fourth approved indication within the European Union. This milestone achievement underscores our unwavering commitment to raising standards of care across a spectrum of IL-17 mediated diseases.”
Notes to editors:
About BE HEARD I and BE HEARD II1
BE HEARD I and BE HEARD II were multicenter, randomized, double-blind, placebo-controlled Phase 3 studies designed to evaluate the efficacy and safety of bimekizumab in adults with moderate to severe hidradenitis suppurativa (HS). The two studies had a combined enrolment of 1,014 adult patients with a diagnosis of moderate to severe HS. The primary endpoint in both studies was HiSCR50 at Week 16. A key secondary endpoint was HiSCR75 at Week 16. 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.
Results from BE HEARD I and BE HEARD II showed that a significantly higher proportion of patients treated with bimekizumab versus 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. Bimekizumab treatment also resulted in clinically meaningful improvements in the ranked key secondary endpoint, HiSCR75 versus placebo at Week 16. Responses were maintained to Week 48. The safety profile of bimekizumab was consistent with safety data seen in previous trials with no new observed safety signals.
About BIMZELX® (bimekizumab)
BIMZELX® (bimekizumab) is a humanized monoclonal IgG1 antibody designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes.1,4 The therapeutic indications in the EU are:1
- Plaque psoriasis: Bimekizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
- Psoriatic arthritis: Bimekizumab, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).
- Axial Spondyloarthritis: Bimekizumab is indicated for the treatment of adults with active non radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C reactive protein (CRP), and/or magnetic resonance imaging (MRI) who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs), and for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.
- Hidradenitis suppurativa: Bimekizumab is indicated for the treatment of active moderate to severe hidradenitis suppurativa (HS; acne inversa) in adults with an inadequate response to conventional systemic HS therapy.
BIMZELX® ▼ (bimekizumab) EU/EEA* Important Safety Information1
The most frequently reported adverse reactions with bimekizumab were upper respiratory tract infections (14.5%, 14.6%, 16.3%, 8.8% in plaque psoriasis, psoriatic arthritis, axial spondyloarthritis (axSpA) and hidradenitis suppurativa, respectively) and oral candidiasis (7.3%, 2.3%, 3.7%, 5.6% in PSO, PsA, axSpA and HS, respectively). Common adverse reactions (≥1/100 to <1/10) were oral candidiasis, tinea infections, ear infections, herpes simplex infections, oropharyngeal candidiasis, gastroenteritis, folliculitis, vulvovaginal mycotic infection (including vulvovaginal candidiasis), headache, rash, dermatitis and eczema, acne, injection site reactions, fatigue. Elderly may be more likely to experience certain adverse reactions such as oral candidiasis, dermatitis and eczema when using bimekizumab.
Bimekizumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients and in patients with clinically important active infections (e.g. active tuberculosis).
Bimekizumab may increase the risk of infections. Treatment with bimekizumab must not be initiated in patients with any clinically important active infection. Patients treated with bimekizumab should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops an infection the patient should be carefully monitored. If the infection becomes serious or is not responding to standard therapy, treatment should be discontinued until the infection resolves. Prior to initiating treatment with bimekizumab, patients should be evaluated for tuberculosis (TB) infection. Bimekizumab should not be given in patients with active TB. Patients receiving bimekizumab should be monitored for signs and symptoms of active TB.
Cases of new or exacerbations of inflammatory bowel disease have been reported with bimekizumab. Bimekizumab is not recommended in patients with inflammatory bowel disease. If a patient develops signs and symptoms of inflammatory bowel disease or experiences an exacerbation of pre-existing inflammatory bowel disease, bimekizumab should be discontinued and appropriate medical management should be initiated.
Serious hypersensitivity reactions including anaphylactic reactions have been observed with IL-17 inhibitors. If a serious hypersensitivity reaction occurs, administration of bimekizumab should be discontinued immediately and appropriate therapy initiated.
Live vaccines should not be given in patients treated with bimekizumab.
Please consult the summary of product characteristics in relation to other side effects, full safety and prescribing information.
European SmPC date of revision: April 2024. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product- information_en.pdf
*EU/EEA means European Union/European Economic Area
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 9,000 people in approximately 40 countries, the company generated revenue of €5.3 billion in 2023. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news.
References
- BIMZELX® (bimekizumab) EU SmPC. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf. April 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.
- Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bimekizumab, a humanized monoclonal antibody and selective dual inhibitor of IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):991–1001.
SOURCE: UCB
Post Views: 1,656
- Marketing authorization in the European Union (EU) represents the first regulatory approval worldwide for bimekizumab in the treatment of moderate to severe hidradenitis suppurativa, and its fourth approved indication within the EU
- Approval is supported by data from two Phase 3 studies, BE HEARD I and BE HEARD II, in which bimekizumab significantly improved the signs of disease compared with placebo at Week 16, which were sustained to Week 48, and was well-tolerated
- Hidradenitis suppurativa is a chronic, relapsing and painful inflammatory skin disease with a significant unmet clinical need for which there are few approved treatment options
BRUSSELS, Belgium I April 22, 2024 I UCB, a global biopharmaceutical company, today announced that the European Commission (EC) has granted marketing authorization for BIMZELX® (bimekizumab) for the treatment of active moderate to severe hidradenitis suppurativa (HS) in adults with an inadequate response to conventional systemic HS therapy.1 The approval follows a positive opinion issued in March 2024 by the Committee for Medicinal Products for Human Use of the European Medicines Agency. The EC approval was granted based on results from two Phase 3 studies, BE HEARD I and BE HEARD II, which evaluated the efficacy and safety of bimekizumab in the treatment of moderate to severe HS.
“The European Commission’s approval of bimekizumab marks a significant milestone for the EU hidradenitis suppurativa community, particularly considering the limited treatment options currently available,” said Prof. Dr. Christos C. Zouboulis, President of the European Hidradenitis Suppurativa Foundation (EHSF) e.V. and Director of the Departments of Dermatology, Venereology, Allergology and Immunology, Städtisches Klinikum Dessau, Brandenburg Medical School, Germany. “As a community, we strive to improve the management of hidradenitis suppurativa. Bimekizumab offers a promising new therapeutic option for moderate to severe disease, supported by Phase 3 evidence that demonstrated clinically meaningful and sustained responses over 48 weeks.”
HS is a chronic, relapsing inflammatory skin disease that manifests as nodules, abscesses and pus-discharging fistulas, i.e., channels leading out of the skin, typically in the armpits, groin, and buttocks.2,3 HS typically starts in early adulthood and affects approximately one percent of the population in most studied countries.2,3 HS is associated with significant co-morbidities and can have a profound negative effect on patients’ quality of life.2,3
“Hidradenitis suppurativa can have a devastating impact on people, especially those with moderate to severe disease. In addition to the physical symptoms, there can also be a considerable psychological burden for many people, resulting in a reduced quality of life and missing out on important life events,” said Barry McGrath, Ph.D., Co-Founder of HS Ireland, an association for all people affected by hidradenitis suppurativa in Ireland. “The possibility of a new treatment option to help people living with this disease is most welcome.”
“We are proud to bring the first and only approved medicine targeting IL-17A and IL-17F to the hidradenitis suppurativa community. We believe that bimekizumab has the potential to transform care for people living with moderate to severe disease,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S. “Today’s approval signifies the expansion of bimekizumab to its fourth approved indication within the European Union. This milestone achievement underscores our unwavering commitment to raising standards of care across a spectrum of IL-17 mediated diseases.”
Notes to editors:
About BE HEARD I and BE HEARD II1
BE HEARD I and BE HEARD II were multicenter, randomized, double-blind, placebo-controlled Phase 3 studies designed to evaluate the efficacy and safety of bimekizumab in adults with moderate to severe hidradenitis suppurativa (HS). The two studies had a combined enrolment of 1,014 adult patients with a diagnosis of moderate to severe HS. The primary endpoint in both studies was HiSCR50 at Week 16. A key secondary endpoint was HiSCR75 at Week 16. 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.
Results from BE HEARD I and BE HEARD II showed that a significantly higher proportion of patients treated with bimekizumab versus 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. Bimekizumab treatment also resulted in clinically meaningful improvements in the ranked key secondary endpoint, HiSCR75 versus placebo at Week 16. Responses were maintained to Week 48. The safety profile of bimekizumab was consistent with safety data seen in previous trials with no new observed safety signals.
About BIMZELX® (bimekizumab)
BIMZELX® (bimekizumab) is a humanized monoclonal IgG1 antibody designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes.1,4 The therapeutic indications in the EU are:1
- Plaque psoriasis: Bimekizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
- Psoriatic arthritis: Bimekizumab, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).
- Axial Spondyloarthritis: Bimekizumab is indicated for the treatment of adults with active non radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C reactive protein (CRP), and/or magnetic resonance imaging (MRI) who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs), and for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.
- Hidradenitis suppurativa: Bimekizumab is indicated for the treatment of active moderate to severe hidradenitis suppurativa (HS; acne inversa) in adults with an inadequate response to conventional systemic HS therapy.
BIMZELX® ▼ (bimekizumab) EU/EEA* Important Safety Information1
The most frequently reported adverse reactions with bimekizumab were upper respiratory tract infections (14.5%, 14.6%, 16.3%, 8.8% in plaque psoriasis, psoriatic arthritis, axial spondyloarthritis (axSpA) and hidradenitis suppurativa, respectively) and oral candidiasis (7.3%, 2.3%, 3.7%, 5.6% in PSO, PsA, axSpA and HS, respectively). Common adverse reactions (≥1/100 to <1/10) were oral candidiasis, tinea infections, ear infections, herpes simplex infections, oropharyngeal candidiasis, gastroenteritis, folliculitis, vulvovaginal mycotic infection (including vulvovaginal candidiasis), headache, rash, dermatitis and eczema, acne, injection site reactions, fatigue. Elderly may be more likely to experience certain adverse reactions such as oral candidiasis, dermatitis and eczema when using bimekizumab.
Bimekizumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients and in patients with clinically important active infections (e.g. active tuberculosis).
Bimekizumab may increase the risk of infections. Treatment with bimekizumab must not be initiated in patients with any clinically important active infection. Patients treated with bimekizumab should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops an infection the patient should be carefully monitored. If the infection becomes serious or is not responding to standard therapy, treatment should be discontinued until the infection resolves. Prior to initiating treatment with bimekizumab, patients should be evaluated for tuberculosis (TB) infection. Bimekizumab should not be given in patients with active TB. Patients receiving bimekizumab should be monitored for signs and symptoms of active TB.
Cases of new or exacerbations of inflammatory bowel disease have been reported with bimekizumab. Bimekizumab is not recommended in patients with inflammatory bowel disease. If a patient develops signs and symptoms of inflammatory bowel disease or experiences an exacerbation of pre-existing inflammatory bowel disease, bimekizumab should be discontinued and appropriate medical management should be initiated.
Serious hypersensitivity reactions including anaphylactic reactions have been observed with IL-17 inhibitors. If a serious hypersensitivity reaction occurs, administration of bimekizumab should be discontinued immediately and appropriate therapy initiated.
Live vaccines should not be given in patients treated with bimekizumab.
Please consult the summary of product characteristics in relation to other side effects, full safety and prescribing information.
European SmPC date of revision: April 2024. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product- information_en.pdf
*EU/EEA means European Union/European Economic Area
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 9,000 people in approximately 40 countries, the company generated revenue of €5.3 billion in 2023. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news.
References
- BIMZELX® (bimekizumab) EU SmPC. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf. April 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.
- Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bimekizumab, a humanized monoclonal antibody and selective dual inhibitor of IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):991–1001.
SOURCE: UCB
Post Views: 1,656
