• Application in moderate-to-severe hidradenitis suppurativa based on results from two Phase 3 studies where BIMZELX^® (bimekizumab-bkzx) showed clinically meaningful improvements vs. placebo at Week 16 which were sustained to Week 48
• Application for the additional BIMZELX 2mL device presentations aims to provide more options to optimize the individual patient experience

ATLANTA, April 4, 2024 – 7:00 a.m (EST)– 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 BIMZELX 2mL device presentations has also been accepted.

“We are excited to share progress on our FDA applications. The most recent sBLA seeks approval for BIMZELX in moderate-to-severe hidradenitis suppurativa, and is aligned to our goal of expanding the reach of BIMZELX 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 BIMZELX 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 BIMZELX this year, following the previously announced applications in psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS). BIMZELX was 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 BIMZELX 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 BIMZELX in the treatment of moderate-to-severe HS, PsA, nr-axSpA, and AS have not been established and these are investigational indications.

The sBLA in moderate-to-severe HS is supported by data from the Phase 3 BE HEARD I and BE HEARD II studies where BIMZELX demonstrated clinically meaningful improvements in HiSCR50 vs. placebo at Week 16, the primary endpoint.² A greater proportion of patients treated with BIMZELX 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 BIMZELX was consistent with previous studies with no new safety signals observed.²

The sBLA for the additional device presentations seeks approval of BIMZELX 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.^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.^3,4

HS most commonly develops in early adulthood and affects approximately one percent of the population in most studied countries.^3,4 Approximately one-third of people with HS have a family history of HS, and lifestyle factors such as smoking and obesity can also play a crucial role in the clinical course of HS.^3,4

The symptoms of pain, discharge, and scarring are not only a physical burden. People with HS also experience stigma: worrying about or directly experiencing negative attitudes and reactions from society in response to their symptoms.⁵ These feelings can lead to embarrassment, social isolation, low self-esteem, and sexual life impairment, and impact all areas of life, including interpersonal relationships, education, and work.⁶

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).^7,8 The two studies had a combined enrollment of 1,014 participants with a diagnosis of moderate-to-severe HS. ^7,8 The primary endpoint in both trials was HiSCR50 at Week 16. ^7,8 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. ^7,8

About BIMZELX (bimekizumab-bkzx)

Bimekizumab 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

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

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

Please see Important Safety Information below and full U.S. prescribing information at www.UCB- USA.com/Innovation/Products/BIMZELX. 

BIMZELX U.S. IMPORTANT SAFETY INFORMATION¹

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 percent) are upper respiratory infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes Simplex Infections, acne, folliculitis, other Candida infections, and fatigue.

For further information, contact UCB:

Investor Relations

Antje Witte

T +32.2.559.94.14

email antje.witte@ucb.com

U.S. Communications

Erica Puntel

T +1.770.970.8465

email erica.puntel@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: @UCBUSA.

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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. 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;12:785–90.
6. Kokolakis G, Wolk K, Schneider-Burrus S, et al. Delayed Diagnosis of Hidradenitis Suppurativa and Its Effect on Patients and Healthcare System. Dermatology. 2020;236:421–430.
7. ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (BE HEARD I). Accessed date: April 2024.
8. ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (BE HEARD II). https://classic.clinicaltrials.gov/ct2/show/NCT04242498. Accessed date: April 2024.