UCB announces positive CHMP opinion for 320 mg device presentations of BIMZELX[®]▼ (bimekizumab)

Brussels (Belgium), 31 May, 2024 – 07:00 (CET) – UCB, a global biopharmaceutical company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending granting marketing authorization for two new device presentations of bimekizumab, a pre-filled syringe and a pre-filled pen, each containing 320 mg in a volume of 2 mL.  

“UCB developed these new device presentations to enhance the individual patient experience. If approved, these new options would allow for a single injection of a 320 mg dose of bimekizumab, simplifying administration and providing increased convenience for patients,” said Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact, Chief Commercial Officer, UCB. 

In the European Union (EU), bimekizumab is currently approved as a 160 mg solution for injection in pre-filled syringe and a 160 mg solution for injection in a pre-filled pen, each with a total volume of 1 mL.¹ In the EU, the recommended dose of bimekizumab for the treatment of moderate to severe plaque psoriasis or active moderate to severe hidradenitis suppurativa is 320 mg, which is administered as two 1 mL injections.¹ If approved by the European Commission (EC), the new device presentations would provide additional options for single-injection administration of 320 mg bimekizumab in a volume of 2 mL. 

The CHMP positive opinion is based on data from studies evaluating the bioequivalence of bimekizumab 320 mg given as one 2mL subcutaneous injection, and bimekizumab 320 mg given as two 1mL subcutaneous injections, in healthy study participants.^2,3

The CHMP’s recommendation will now be reviewed by the EC for marketing authorization in the European Union, as well as countries of the European Economic Area. A final decision is expected within approximately two months.

Notes to editors:

About bimekizumab in the EU
Bimekizumab 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.⁴

The therapeutic indications in the EU are¹: 

• 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. 

The label information may differ in other countries where approved. Please check local prescribing information. In countries outside of the EU, bimekizumab is not currently approved for the treatment of active moderate to severe HS. 

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.

Last accessed: May 2024.

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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References

1. BIMZELX^® (bimekizumab) EU SmPC. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf. Accessed May 2024.
2. ClinicalTrials.Gov. NCT05292131 Available at https://classic.clinicaltrials.gov/ct2/show/NCT05292131. Accessed May 2024.   
3. ClinicalTrials.Gov. NCT04255862 Available at https://classic.clinicaltrials.gov/ct2/show/NCT04255862?term=UP0068&draw=2&rank=1.  Accessed May 2024
4. 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.