UCB receives positive CHMP opinion for BIMZELX[®]▼(bimekizumab) for the treatment of adults with moderate to severe hidradenitis suppurativa

Brussels (Belgium), 22 March 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 issued a positive opinion recommending granting marketing authorization for BIMZELX^® (bimekizumab) in the European Union (EU)/European Economic Area (EEA) for the treatment of active moderate to severe hidradenitis suppurativa (HS; acne inversa) in adults with an inadequate response to conventional systemic HS therapy. If approved by the European Commission (EC), bimekizumab will be the first IL-17A and IL-17F inhibitor approved in the EU for the treatment of adults with moderate to severe HS.

“The positive opinion from the CHMP represents a significant milestone toward bringing bimekizumab to people living with moderate to severe hidradenitis suppurativa, a chronic, painful inflammatory skin disease with limited treatment options,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions, and Head of U.S., UCB.  “If approved by the European Commission, this would represent the fourth marketing authorization for bimekizumab in three years, adding to the existing indications in moderate to severe plaque psoriasis, active psoriatic arthritis and active axial spondyloarthritis.” 
 
HS is a chronic 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.¹ HS affects approximately one percent of the population in most studied countries with those affected experiencing flare-ups of the disease as well as severe pain.^1,2,3  People living with HS also experience social stigma, social isolation and low self-esteem, all of which have a major impact on their quality of life.^2,3 

The CHMP positive opinion for bimekizumab is based on findings from the Phase 3 BE HEARD I and BE HEARD II studies which evaluated the efficacy and safety of bimekizumab in the treatment of adults with moderate to severe HS.^4,5  Data showed that bimekizumab treatment resulted in statistically significant and clinically meaningful improvements over placebo in the signs and symptoms of HS, as measured by HiSCR50 at Week 16, the primary endpoint, with responses sustained to Week 48.^4,5 Bimekizumab treatment also resulted in improvements over placebo in the high threshold endpoint, HiSCR75 at Week 16, a key ranked secondary endpoint, with responses sustained to Week 48.^4,5 In both studies the safety profile of bimekizumab was consistent with data seen in previous studies with no new observed safety signals.^4,5 

The CHMP positive opinion on bimekizumab in moderate to severe HS will be referred to the EC for its final decision. The marketing authorization would be applicable to all EU member states as well as countries of the EEA.

Notes to editors:

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 bimekizumab in adults with moderate to severe hidradenitis suppurativa (HS).^4,5 The two studies had a combined enrolment of 1,014 participants with a diagnosis of moderate to severe HS. The primary endpoint in both studies was HiSCR50 at Week 16.^4,5 A key ranked secondary endpoint was HiSCR75 at Week 16.^4,5 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.^4,5

About BIMZELX^® (bimekizumab)

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.⁶ The therapeutic indications in the European Union are:⁷

• Plaque psoriasis: Bimekizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.⁷ 
• 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).⁷ 
• 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.⁷ 

BIMZELX^® (bimekizumab) EU/EEA* Important Safety Information⁷

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 and fatigue. Elderly individuals 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.⁷ 

European SmPC date of revision: November 2023. 
Last accessed: March 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.

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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.   Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. Nat Rev Dis Primers. 2020;6(1):18.
2.   Koumaki D, Efthymiou O, Bozi E, et al. Perspectives On Perceived Stigma And Self-Stigma In Patients With Hidradenitis Suppurativa. Clin Cosmet Investig Dermatol. 2019;12(1):785–90.
3.   Kokolakis G, Wolk K, Schneider-Barrus S, et al. Delayed Diagnosis of Hidradenitis Suppurativa and Its Effect on Patients and Healthcare System. Dermatology. 2020;236(5):421–30.
4.   Kimball AB, Zouboulis CC, Sayed C, et al. Bimekizumab in patients with moderate-to-severe hidradenitis suppurativa: 48-week   efficacy and safety from BE HEARD I & II, two phase 3, randomized, double-blind, placebo controlled, multicenter studies. Late-Breaking Platform Presentation at the American Academy of Dermatology Congress 2023.
5.   Zouboulis C. 2023 EADV. Session S042-45981.
6.   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.
7.   BIMZELX^® (bimekizumab) EU SmPC. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf. Accessed March 2024.