https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0r=
CyBv9bezcPT-2BuItTLKIHepbxTbo-2FYbVFPSBekB-2Bmk9X7Kl8shoTE6BsSbYYjHYcOVCrOC=
rjYrJUHPDVbu1NKaBE-3DxxLN_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2=
FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLN=
n-2B6FohpNoV33EIfh7JrrTBvNRLtG5Nps6v-2BaYlDVNGRj5fP6ozk7SdypmAJOSEPkCILZg9I=
TTRY91v0NDW49ovP012aIx4QV7b-2B6NymX7Y8t2jyS9RCCJKKx2SES711KCINj6T3xru7s2Wle=
cA5Suop4dzURZDtIjGmLnEvZHU4TxtSVfo-2B1Pdr9xOdRQUeGMdtNP0D-2BkUP5ie22jHtawpe=
6bbti266Jyrhz7FihyZpaxXwnre9VVdI-3D
** UCB receives European Commission approval for BIMZELX^=C2=AE=E2=96=BC(bi=
mekizumab) as the first IL-17A and IL-17F biologic for moderate to severe h=
idradenitis suppurativa
------------------------------------------------------------
=C2=B7 Marketing authorization in the European Union (EU) represents the fi=
rst regulatory approval worldwide for bimekizumab in the treatment of moder=
ate to severe hidradenitis suppurativa, and its fourth approved indication =
within the EU
=C2=B7 Approval is supported by data from two Phase 3 studies, BE HEARD I a=
nd BE HEARD II, in which bimekizumab significantly improved the signs of di=
sease compared with placebo at Week 16, which were sustained to Week 48, an=
d was well-tolerated=C2=A0
=C2=B7 Hidradenitis suppurativa is a chronic, relapsing and painful inflamm=
atory skin disease with a significant unmet clinical need for which there a=
re few approved treatment options
Brussels (Belgium), 22 April 2024 =E2=80=93 07:00 (CET) =E2=80=93 UCB, a gl=
obal biopharmaceutical company, today announced that the European Commissio=
n (EC) has granted marketing authorization for BIMZELX^=C2=AE (bimekizumab)=
for the treatment of active moderate to severe hidradenitis suppurativa (H=
S) in adults with an inadequate response to conventional systemic HS therap=
y.^1 The approval follows a positive opinion issued in March 2024 by the Co=
mmittee for Medicinal Products for Human Use of the European Medicines Agen=
cy. The EC approval was granted based on results from two Phase 3 studies, =
BE HEARD I and BE HEARD II, which evaluated the efficacy and safety of bime=
kizumab in the treatment of moderate to severe HS.=C2=A0
=E2=80=9CThe European Commission=E2=80=99s approval of bimekizumab marks a =
significant milestone for the EU hidradenitis suppurativa community, partic=
ularly considering the limited treatment options currently available,=E2=80=
=9D said Prof. Dr. Christos C. Zouboulis, President of the European Hidrade=
nitis Suppurativa Foundation (EHSF) e.V. and Director of the Departments of=
Dermatology, Venereology, Allergology and Immunology, St=C3=A4dtisches Kli=
nikum Dessau, Brandenburg Medical School, Germany. =E2=80=9CAs a community,=
we strive to improve the management of hidradenitis suppurativa. Bimekizum=
ab offers a promising new therapeutic option for moderate to severe disease=
, supported by Phase 3 evidence that demonstrated clinically meaningful and=
sustained responses over 48 weeks.=E2=80=9D=C2=A0
HS is a chronic, relapsing inflammatory skin disease that manifests as nodu=
les, abscesses and pus-discharging fistulas, i.e., channels leading out of =
the skin, typically in the armpits, groin, and buttocks.^2,3=C2=A0 HS typic=
ally starts in early adulthood and affects approximately one percent of the=
population in most studied countries.^2,3 HS is associated with significan=
t co-morbidities and can have a profound negative effect on patients=E2=80=
=99 quality of life.^2,3=C2=A0
=E2=80=9CHidradenitis suppurativa can have a devastating impact on people, =
especially those with moderate to severe disease. In addition to the physic=
al symptoms, there can also be a considerable psychological burden for many=
people, resulting in a reduced quality of life and missing out on importan=
t life events,=E2=80=9D said Barry McGrath, Ph.D., Co-Founder of HS Ireland=
, an association for all people affected by hidradenitis suppurativa in Ire=
land. =E2=80=9CThe possibility of a new treatment option to help people liv=
ing with this disease is most welcome.=E2=80=9D
=E2=80=9CWe are proud to bring the first and only approved medicine targeti=
ng IL-17A and IL-17F to the hidradenitis suppurativa community. We believe =
that bimekizumab has the potential to transform care for people living with=
moderate to severe disease,=E2=80=9D said Emmanuel Caeymaex, Executive Vic=
e President, Immunology Solutions and Head of U.S. =E2=80=9CToday=E2=80=99s=
approval signifies the expansion of bimekizumab to its fourth approved ind=
ication within the European Union. This milestone achievement underscores o=
ur unwavering commitment to raising standards of care across a spectrum of =
IL-17 mediated diseases.=E2=80=9D
Notes to editors:
About BE HEARD I and BE HEARD II^1
BE HEARD I and BE HEARD II were multicenter, randomized, double-blind, plac=
ebo-controlled Phase 3 studies designed to evaluate the efficacy and safety=
of bimekizumab in adults with moderate to severe hidradenitis suppurativa =
(HS). The two studies had a combined enrolment of 1,014 adult patients with=
a diagnosis of moderate to severe HS. The primary endpoint in both studies=
was HiSCR50 at Week 16. A key secondary endpoint was HiSCR75 at Week 16. H=
iSCR50 and HiSCR75 are defined as at least either a 50 or 75 percent reduct=
ion from baseline in the total abscess and inflammatory nodule count, with =
no increase from baseline in abscess or draining tunnel count.=C2=A0
Results from BE HEARD I and BE HEARD II showed that a significantly higher =
proportion of patients treated with bimekizumab versus placebo achieved a 5=
0 percent or greater improvement in HS signs and symptoms at Week 16, as me=
asured by HiSCR50, the primary endpoint in both trials. Bimekizumab treatme=
nt also resulted in clinically meaningful improvements in the ranked key se=
condary endpoint, HiSCR75 versus placebo at Week 16. =C2=A0Responses were m=
aintained to Week 48. The safety profile of bimekizumab was consistent with=
safety data seen in previous trials with no new observed safety signals.
About BIMZELX^=C2=AE (bimekizumab)
BIMZELX^=C2=AE (bimekizumab) is a humanized monoclonal IgG1 antibody design=
ed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F=
(IL-17F), two key cytokines driving inflammatory processes.^1,4=C2=A0 The =
therapeutic indications in the EU are:^1
=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.=C2=A0
=C2=B7 Psoriatic arthritis: Bimekizumab, alone or in combination with metho=
trexate, is indicated for the treatment of active psoriatic arthritis in ad=
ults who have had an inadequate response or who have been intolerant to one=
or more disease-modifying antirheumatic drugs (DMARDs).=C2=A0
=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.=C2=A0
=C2=B7 Hidradenitis suppurativa: Bimekizumab is indicated for the treatment=
of active moderate to severe hidradenitis suppurativa (HS; acne inversa) i=
n adults with an inadequate response to conventional systemic HS therapy.
BIMZELX^=C2=AE =E2=96=BC (bimekizumab) EU/EEA* Important Safety Information=
^1
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 sup=
purativa, respectively) and oral candidiasis (7.3%, 2.3%, 3.7%, 5.6% in PSO=
, PsA, axSpA and HS, respectively). Common adverse reactions (=E2=89=A51/10=
0 to <1/10) were oral candidiasis, tinea infections, ear infections, herpes=
simplex infections, oropharyngeal candidiasis, gastroenteritis, folliculit=
is, vulvovaginal mycotic infection (including vulvovaginal candidiasis), he=
adache, rash, dermatitis and eczema, acne, injection site reactions, fatigu=
e. 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 act=
ive substance or to any of the excipients and in patients with clinically i=
mportant 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 including anaphylactic reactions have be=
en observed with IL-17 inhibitors. If a serious hypersensitivity reaction o=
ccurs, 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://u7061146.ct.sendgrid.ne=
t/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rC2tJ60H3Fdk1VajTAIAj7NPJeYj-2Ba=
-2BL1r-2B0jLM-2FtfvSeD3KLQsazq58-2BxwfyV7LSQd4uSQwA6JMudpi5XOwHZtxZSt9alTJN=
B3GCtxa-2FoK-2BOTzRR_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z=
2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6=
FohpNoV33EIfh7JrrTBvNRLtG5Nps6v-2BaYlDVNGRj5fP6ozk7SdypmAJOSEPkCILZg9ITTRY9=
1v0NDW49ovP012aIx4QV7buE3kJ-2B4tWTu5LIAsN4tuhv1-2BDpNEy1WtFtZC6c-2BYOctVKot=
nvUxCIatg2uf-2FRj5s-2FeeLXxCKJfDZedqCAHNqJJAHppgtGYN-2F-2BzzNCoN1ONmAObIOT7=
kj5hdjs5pJNPoF-2FNpJxWIi4HX783fVEMAVI-3D information_en.pdf=C2=A0 (https://=
u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rC2tJ60H3=
Fdk1VajTAIAj7NPJeYj-2Ba-2BL1r-2B0jLM-2FtfvSeD3KLQsazq58-2BxwfyV7LSQd4uSQwA6=
JMudpi5XOwHZtyAHZJBd6YRdp1RSNV5wqOW-2B2nuMhJvPUY2IJDXRoqHUQ-3D-3Dv6ar_2dCLU=
NbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6=
ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33EIfh7JrrTBvNRLtG5=
Nps6v-2BaYlDVNGRj5fP6ozk7SdypmAJOSEPkCILZg9ITTRY91v0NDW49ovP012aIx4QV7THONN=
FktRQw45OfEG1DK4PFmeS3byzaioe9QG-2FhQScVa5fnm1eM1iv4v9VuGJvX-2Fp-2Bl02NPKWm=
Odc2J-2F8Hz2uJRaJZOhMNVnZ2Lbs5Hg91TpyKi-2B79EpQXMB-2F0ooag-2Br4KiKRLBA6bdU0=
IqkoeSBUw-3D
*EU/EEA means European Union/European Economic Area
=E2=96=BC=C2=A0This 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 9,000 peopl=
e in approximately 40 countries, the company generated revenue of =E2=82=AC=
5.3 billion in 2023. UCB is listed on Euronext Brussels (symbol: UCB). Foll=
ow us on Twitter: @UCB_news.
Forward looking statements=C2=A0
This press release may contain forward-looking statements including, withou=
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=
inue=E2=80=9D and similar expressions. These forward-looking statements are=
based on current plans, estimates and beliefs of management. All statement=
s, other than statements of historical facts, are statements that could be =
deemed forward-looking statements, including estimates of revenues, operati=
ng margins, capital expenditures, cash, other financial information, expect=
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ing statements are not guarantees of future performance and are subject to =
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or industry results, to differ materially from those that may be expressed =
or implied by such forward-looking statements contained in this press relea=
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ms or within expected timing, costs associated with research and developmen=
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ctuations, changes or uncertainties in tax laws or the administration of su=
ch laws, and hiring and retention of its employees. There is no guarantee t=
hat new product candidates will be discovered or identified in the pipeline=
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oducts will be developed and approved. Movement from concept to commercial =
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Given these uncertainties, you should not place undue reliance on any of su=
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References
1. BIMZELX^=C2=AE (bimekizumab) EU SmPC. https://u7061146.ct.sendgrid.net/l=
s/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rC2tJ60H3Fdk1VajTAIAj7NPJeYj-2Ba-2B=
L1r-2B0jLM-2FtfvSeD3KLQsazq58-2BxwfyV7LSQd4uSQwA6JMudpi5XOwHZtyAHZJBd6YRdp1=
RSNV5wqOWwE2cRsny7Ehx4x7oG7pgXg-3D-3D_xDv_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFG=
M-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8=
cV3s33SbkEZvEGLNn-2B6FohpNoV33EIfh7JrrTBvNRLtG5Nps6v-2BaYlDVNGRj5fP6ozk7Sdy=
pmAJOSEPkCILZg9ITTRY91v0NDW49ovP012aIx4QV7VvvD7LiLIyCGQfqPGEx0frggAwjsau353=
9ru62-2FUxKmW13bMtB1mQks1UDugWCj9MxIeMjmVB4vHJF-2Bqg4HNwMg7dvifg8KKks5MXnWD=
hFO67hq73CU6TecI27LEKk-2FpIEYJlyhhxurvsoMuINCvpc-3D April 2024.
2. Jemec GB. Clinical practice: hidradenitis suppurativa. N Engl J Med. 201=
2;366(2):158-64.
3. Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. Nat Rev=
Dis Primers. 2020;6(1):18.
4. 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=
=E2=80=931001.
GenericFile
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-3D
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