FDA Accepts Supplemental Biologics License Applications for BIMZELX[®] (bimekizumab-bkzx) for Moderate to Severe Hidradenitis Suppurativa and Additional 2mL Device Presentations

Brussels (Belgium), April 4, 2024 – 07:00 (CET) – UCB, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for BIMZELX^® (bimekizumab-bkzx), an IL-17A and IL-17F inhibitor, for the treatment of adults with moderate to severe hidradenitis suppurativa (HS). In addition, a second sBLA for the bimekizumab-bkzx 2mL device presentations has also been accepted.

“We are excited to share the progress on our FDA applications. The most recent sBLA seeks approval for bimekizumab-bkzx in moderate to severe hidradenitis suppurativa, and is aligned to our goal of expanding the reach of bimekizumab to more patients living with IL-17 mediated diseases,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions, and Head of U.S., UCB. “In addition, the sBLA for the 2mL device presentations aims to offer increased convenience for patients. Today, one dose of bimekizumab in moderate to severe plaque psoriasis, is administered as two 1mL injections. Approval of the 2mL device presentations would mean that patients would have an alternative one injection regimen option.” 

These new regulatory milestones represent two of five sBLAs accepted by the FDA for bimekizumab-bkzx in 2024, following the previously announced applications in psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS). BIMZELX^® was first approved in the U.S. in October 2023 for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.¹ Bimekizumab-bkzx is not approved in the U.S. for the treatment of moderate to severe HS, PsA, nr-axSpA and AS, or for the 2mL device presentation. In the U.S., the efficacy and safety of bimekizumab-bkzx in the treatment of moderate to severe HS, PsA, nr-axSpA and AS have not been established and these are investigational indications only. 

The sBLA in moderate to severe HS is supported by data from the Phase 3 BE HEARD I and BE HEARD II studies where bimekizumab-bkzx demonstrated clinically meaningful improvements in HiSCR50 vs. placebo at Week 16, the primary endpoint.² A greater proportion of patients treated with bimekizumab vs. placebo also achieved HiSCR75 at Week 16, a key secondary endpoint.² In addition, over 48 weeks, improvements increased for patients in these studies.² The safety profile of bimekizumab-bkzx was consistent with previous studies with no new safety signals observed.²  

The sBLA for the additional device presentations seeks approval of bimekizumab-bkzx 2mL safety syringe and 2mL autoinjector with the aim of providing a second option to the currently approved 1mL presentations.

Notes to editors:

About hidradenitis suppurativa (HS)

Hidradenitis suppurativa (HS) is a chronic, recurring, painful, and debilitating inflammatory skin disease that is associated with systemic manifestations.^3,4  The main symptoms are nodules, abscesses, and pus-discharging tunnels (channels leading out of the skin) which typically occur in the armpits, groin, and buttocks.^3,4 People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life. HS develops in early adulthood and affects approximately one percent of the population in most studied countries.^3,4 

About BE HEARD I and BE HEARD II

The efficacy and safety of bimekizumab-bkzx were evaluated in adult patients with moderate to severe hidradenitis suppurativa (HS) in two multicentre, randomized, double-blind, placebo-controlled Phase 3 studies (BE HEARD I and BE HEARD II). The two studies had a combined enrolment of 1,014 participants with a diagnosis of moderate to severe HS.^5,6  The primary endpoint in both trials was HiSCR50 at Week 16.^5,6 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.^5,6 

About BIMZELX^®

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.⁷

In the U.S., bimekizumab-bkzx is approved for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.¹ Bimekizumab-bkzx is not approved in the U.S. for the treatment of moderate to severe HS, PsA, nr-axSpA and AS, or for the 2mL device presentation. In the U.S., the efficacy and safety of bimekizumab-bkzx in the treatment of moderate to severe HS, PsA, r-axSpA and AS have not been established and these are investigational indications only. 

Bimekizumab is not approved in HS by any regulatory authority worldwide. 

The approved indications for bimekizumab ▼ in the European Union are⁸:

• 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. 

The label information may differ in other countries where approved. Please check local prescribing information. 

BIMZELX^® U.S. IMPORTANT SAFETY INFORMATION¹

Please see Important Safety Information below and full U.S. prescribing information at www.ucb-usa.com/Innovation/Products/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 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, advise 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. 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

Most common adverse reactions (≥ 1%) are upper respiratory infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes Simplex Infections, acne, folliculitis, other Candida infections, and fatigue.

BIMZELX^® ▼ (bimekizumab) EU/EEA* Important Safety Information⁸

The most frequently reported adverse reactions with bimekizumab were upper respiratory tract infections (14.5%, 14.6%, 16.3% in plaque psoriasis (PSO), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA), respectively) and oral candidiasis (7.3%, 2.3%, 3.7% in PSO, PsA and axSpA, respectively). Common adverse reactions (≥1/100 to <1/10) were oral candidiasis, tinea infections, ear infections, herpes simplex infections, oropharyngeal candidiasis, gastroenteritis, folliculitis, 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 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: November 2023.

https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf 

Last accessed: April 2024.

*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 

For further information, contact UCB: 

Investor Relations
Antje Witte
T +32.2.559.94.14 
email antje.witte@ucb.com 

Corporate Communications
Laurent Schots 
T +32.2.559.92.64 
email laurent.schots@ucb.com

Brand Communications
Eimear O’Brien
T +32.2.559.92.71
email eimear.obrien@ucb.com 

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.

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Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future.

UCB is providing this information, including forward-looking statements, only as of the date of this press release. UCB expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations. 

Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. 

References 

1. BIMZELX^® (bimekizumab-bkzx) U.S. PI. Available at: https://www.ucb-usa.com/Innovation/Products/BIMZELX. Last accessed: April 2024.
2. Zouboulis C. 2023, EADV 2023, Oral Presentation # 3262 
3. Jemec GBE. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012;366(2):158-64.
4. Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. Nat Rev Dis Primers. 2020;6(18):1-20.
5. ClinicalTrials.gov. NCT04242446. Available at: https://clinicaltrials.gov/ct2/show/NCT04242446?term=be+heard&draw=2&rank=1. Last accessed date: April 2024.
6. ClinicalTrials.gov. NCT04242498. Available at: https://clinicaltrials.gov/ct2/show/NCT04242498. Last accessed date: April 2024.
7. 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.
8. BIMZELX^® (bimekizumab) EU SmPC. Available at https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf Last accessed: April 2024.