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** UCB Announces EU Regulatory Filing for Bimekizumab for the Treatment of =
Moderate to Severe Hidradenitis Suppurativa
------------------------------------------------------------
=C2=B7 Regulatory filing supported by data from two bimekizumab Phase 3 stu=
dies in hidradenitis suppurativa
=C2=B7 Hidradenitis suppurativa is a chronic, painful, inflammatory skin co=
ndition that is associated with systemic manifestations, and affects approx=
imately 1 in 100 people=C2=A0
Brussels (Belgium), 18th July 2023 =E2=80=93 07:00 (CEST) =E2=80=93 UCB, a =
global biopharmaceutical company, today announced that the European Medicin=
es Agency (EMA) has accepted for review the marketing authorization applica=
tion for bimekizumab, an IL-17A and IL-17F inhibitor, for the treatment of =
adults with moderate to severe hidradenitis suppurativa (HS).
=E2=80=9CThis EU regulatory submission for bimekizumab reflects our pursuit=
to address unmet patient needs and to advance standards of care in hidrade=
nitis suppurativa, especially given that few treatment options are availabl=
e today. If approved, this would represent the fourth indication for bimeki=
zumab in the European Union across a range of IL-17 mediated diseases,=E2=
=80=9D said Emmanuel Caeymaex, Executive Vice President, Immunology Solutio=
ns and Head of U.S., UCB.=C2=A0
The application for HS is supported by data from the Phase 3 BE HEARD I and=
BE HEARD II studies which were previously communicated (https://www.ucb.co=
m/stories-media/Press-Releases/article/Bimekizumab-Phase-3-Data-in-Hidraden=
itis-Suppurativa-Show-Clinically-Meaningful-Deep-and-Maintained-Response-ov=
er-48-Weeks) .^1 In both studies, bimekizumab demonstrated statistically si=
gnificant and clinically meaningful improvements over placebo in signs and =
symptoms of HS at week 16, as measured by HiSCR50, the primary endpoint in =
the two studies, with maintained response to Week 48.^1* Patients treated w=
ith bimekizumab also achieved deep levels of clinical response with a great=
er proportion achieving HiSCR75, a key secondary endpoint, at week 16 than =
placebo.^1 The safety profile of bimekizumab across BE HEARD I and BE HEARD=
II was consistent with previous bimekizumab studies with no new safety sig=
nals observed.^1=C2=A0
In August 2021, bimekizumab=E2=96=BC first received marketing authorization=
in countries of the European Union (EU)/European Economic Area (EEA) for t=
he treatment of moderate to severe plaque psoriasis in adults who are candi=
dates for systemic therapy.^2 In June 2023, bimekizumab was approved in cou=
ntries of the EU/EEA for the treatment of adults with active psoriatic arth=
ritis, and for the treatment of adults with active axial spondyloarthritis =
(axSpA), including non-radiographic axSpA and ankylosing spondylitis, also =
known as radiographic axSpA.^2
The safety and efficacy of bimekizumab in HS have not been established, and=
it is not approved for use in HS by any regulatory authority worldwide.=C2=
=A0=C2=A0 =C2=A0
Notes to editors:
*p=3D0.006 and p=3D0.003 for BE HEARD I and BE HEARD II, respectively with =
bimekizumab every two weeks (Q2W); p=3D0.030 and p=3D0.004 for BE HEARD I a=
nd BE HEARD II, respectively with bimekizumab every four weeks (Q4W).
About Hidradenitis Suppurativa (HS)
Hidradenitis suppurativa (HS) is a chronic, recurring, painful, and debilit=
ating inflammatory skin disease, that is associated with systemic manifesta=
tions.^3,4 The main symptoms are nodules, abscesses, and pus-discharging fi=
stulas (channels leading out of the skin) which typically occur in the armp=
its, groin and buttocks.^3,4 People with HS experience flare-ups of the dis=
ease as well as severe pain, which can have a major impact on quality of li=
fe.^3,4
HS develops in early adulthood, affects approximately one percent of the po=
pulation in most studied countries.^3,4 Approximately one third of people w=
ith HS have a family history of HS, and lifestyle factors such as smoking a=
nd obesity can also play a crucial role in the clinical course of HS.^5=C2=
=A0
The symptoms of pain, discharge and scarring are not only a physical burden=
. People with HS also experience stigma: worrying about or directly experie=
ncing negative attitudes and reactions from society in response to their sy=
mptoms.^6 These feelings can lead to embarrassment, social isolation, low s=
elf-esteem and sexual life impairment, and impact all areas of life, includ=
ing interpersonal relationships, education and work.^3,5=C2=A0
About BE HEARD I and BE HEARD II
BE HEARD I is a randomized, double-blind, placebo-controlled, parallel grou=
p, multicenter, Phase 3 study designed to evaluate the efficacy and safety =
of bimekizumab in adults with moderate to severe hidradenitis suppurativa (=
HS).^7 BE HEARD II is a randomized, double-blind, placebo-controlled, paral=
lel group, multicenter, Phase 3 study designed to evaluate the efficacy and=
safety of bimekizumab in adults with moderate to severe HS.^8 The two stud=
ies had a combined enrolment of 1,014 participants with a diagnosis of mode=
rate to severe HS.^7,8 The primary endpoint in both studies was HiSCR50 at =
week 16.^8 A key secondary endpoint was HiSCR75 at week 16. HiSCR50 and HiS=
CR75 are defined as at least either a 50 or 75 percent reduction from basel=
ine in the total abscess and inflammatory nodule count, with no increase fr=
om baseline in abscess or draining tunnel count.^7,8 The two studies evalua=
ted two dose regimens of bimekizumab (320 mg every two weeks [Q2W] and 320 =
mg every four weeks [Q4W]) versus placebo over the 16-week initial and the =
32-week maintenance treatment periods.^7,8=C2=A0
About bimekizumab
Bimekizumab is a humanized monoclonal IgG1 antibody that is designed to sel=
ectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F)=
, two key cytokines driving inflammatory processes.^9 The therapeutic indic=
ations in the European Union are:
=C2=B7 Plaque psoriasis: Bimekizumab is indicated for the treatment of mode=
rate to severe plaque psoriasis in adults who are candidates for systemic t=
herapy.^2
=C2=B7 Psoriatic arthritis: Bimekizumab is indicated alone or in combinatio=
n with methotrexate, for the treatment of active psoriatic arthritis in adu=
lts who have had an inadequate response or who have been intolerant to one =
or more disease-modifying antirheumatic drugs (DMARDs).^2
=C2=B7 Axial Spondyloarthritis: Bimekizumab is indicated for the treatment =
of adults with active non-radiographic axial spondyloarthritis with objecti=
ve 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 respond=
ed inadequately or are intolerant to conventional therapy.^2
BIMZELX^=C2=AE =E2=96=BC=C2=A0(bimekizumab) EU/EEA* Important Safety Inform=
ation
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), respective=
ly) and oral candidiasis (7.3%, 2.3%, 3.7% in PSO, PsA and axSpA, respectiv=
ely). Common adverse reactions (=E2=89=A51/100 to <1/10) were oral candidia=
sis, tinea infections, ear infections, herpes simplex infections, oropharyn=
geal candidiasis, gastroenteritis, folliculitis, headache, rash, dermatitis=
and eczema, acne, injection site reactions, fatigue. Elderly may be more l=
ikely to experience certain adverse reactions such as oral candidiasis, der=
matitis and eczema when using bimekizumab.
Bimekizumab is contraindicated in patients with hypersensitivity to the act=
ive substance or any of the excipients and in patients with clinically impo=
rtant 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 inf=
ection. Patients treated with bimekizumab should be instructed to seek medi=
cal advice if signs or symptoms suggestive of an infection occur. If a pati=
ent develops an infection the patient should be carefully monitored. If the=
infection becomes serious or is not responding to standard therapy, treatm=
ent should be discontinued until the infection resolves. Prior to initiatin=
g 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 repor=
ted with bimekizumab. Bimekizumab is not recommended in patients with infla=
mmatory bowel disease. If a patient develops signs and symptoms of inflamma=
tory bowel disease or experiences an exacerbation of pre-existing inflammat=
ory bowel disease, bimekizumab should be discontinued and appropriate medic=
al management should be initiated. Serious hypersensitivity reactions inclu=
ding anaphylactic reactions have been observed with IL-17 inhibitors. If a =
serious hypersensitivity reaction occurs, administration of bimekizumab sho=
uld 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: June 2023.
http://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-prod=
uct-information_en.pdf
*EU/EEA means European Union/European Economic Area
=E2=96=BC=C2=A0 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:=C2=A0
Investor Relations
Antje Witte
T +32.2.559.94.14=C2=A0
email antje.witte@ucb.com=C2=A0
Corporate Communications
Laurent Schots=C2=A0
T +32.2.559.92.64=C2=A0
email laurent.schots@ucb.com
Brand Communications
Eimear O=E2=80=99Brien
T +32.2.559.92.71
email eimear.obrien@ucb.com=C2=A0
About UCB=C2=A0
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company =
focused on the discovery and development of innovative medicines and soluti=
ons to transform the lives of people living with severe diseases of the imm=
une system or of the central nervous system. With approximately 8,700 peopl=
e in approximately 40 countries, the company generated revenue of =E2=82=AC=
5.5 billion in 2022 UCB is listed on Euronext Brussels (symbol: UCB). Follo=
w us on Twitter: @UCB_news.
Forward looking statements=C2=A0
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t limitation, statements containing the words =E2=80=9Cbelieves=E2=80=9D, =
=E2=80=9Canticipates=E2=80=9D, =E2=80=9Cexpects=E2=80=9D, =E2=80=9Cintends=
=E2=80=9D, =E2=80=9Cplans=E2=80=9D, =E2=80=9Cseeks=E2=80=9D, =E2=80=9Cestim=
ates=E2=80=9D, =E2=80=9Cmay=E2=80=9D, =E2=80=9Cwill=E2=80=9D, =E2=80=9Ccont=
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Given these uncertainties, you should not place undue reliance on any of su=
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UCB is providing this information, including forward-looking statements, on=
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References
1. Kimball AB, Zouboulis CC, Sayed C, et al. Bimekizumab in patients with m=
oderate-to-severe hidradenitis suppurativa: 48-week efficacy and safety fro=
m BE HEARD I & II, two phase 3, randomized, double-blind, placebo controlle=
d, multicenter studies. Late-Breaking Platform Presentation at the 2023 Ame=
rican Academy of Dermatology Annual Meeting.
2. BIMZELX (bimekizumab) EU Summary of Product Characteristics. Available a=
t: http://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-p=
roduct-information_en.pdfhttps://www.ema.europa.eu/en/documents/product-inf=
ormation/bimzelx-epar-product-information_en.pdf Last accessed: July 2023
3. Jemec GBE. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 20=
12;366(2):158-164.
4. Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. Nat Rev=
Dis Primers. 2020;6:18.
5. Kokolakis G, Wolk K, Schneider-Burrus S, et al. Delayed Diagnosis of Hid=
radenitis Suppurativa and Its Effect on Patients and =C2=A0 =C2=A0 Healthca=
re System. Dermatology. 2020;236:421=E2=80=93430.
6. Koumaki D, Ourania E, Bozi E, et al. Perspectives On Perceived Stigma An=
d Self-Stigma In Patients With Hidradenitis Suppurativa. Clin Cosmet Invest=
ig Dermatol. 2019;12:785=E2=80=93790.
7. ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimek=
izumab in Study Participants With Moderate to Severe Hidradenitis Suppurati=
va (BE HEARD I). Available at: https://clinicaltrials.gov/ct2/show/NCT04242=
446?term=3Dbe+heard&draw=3D2&rank=3D1 (https://classic.clinicaltrials.gov/c=
t2/show/NCT04242446?term=3Dbe+heard&draw=3D2&rank=3D1) . Last accessed: Jul=
y 2023=C2=A0
8. ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimek=
izumab in Study Participants With Moderate to Severe Hidradenitis Suppurati=
va (BE HEARD II). Available at: https://clinicaltrials.gov/ct2/show/NCT0424=
2498 Last accessed: July 2023
9. Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bi=
mekizumab, a humanized monoclonal antibody and selective dual inhibitor of =
IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):991-1=
001.
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