https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0r=
CyBv9bezcPT-2BuItTLKIHepbxTbo-2FYbVFPSBekB-2Bmk9X7Kl8shoTE6BsSbYYjHYcOVCrOC=
rjYrJUHPDVbu1NKaBE-3D47g-_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2=
FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLN=
n-2B6FohpNoV33bmOTT4LtKtILLAgjlSzidGq5pfvIrElAmFCJi75egfAudmPkzxR-2FgEZTHLQ=
1mQAC7CXybuA7MypxYhMKhmSc6DzKzOwYaY032yDZF87UaTJ0-2BJ7xyyu4sD6RNySuh6ZMDS-2=
FVFhRVDAl6IRigz2SuX-2BUjylcWiwBEMjIcfT61K2RHoR0Ne1Ml8fAEvwz4aCINlw7jPJ26kom=
RRyXqssadvI81dRHb6iKYzrVATg0Wtnw-3D
** UCB receives positive CHMP opinion for BIMZELX^=C2=AE=E2=96=BC(bimekizum=
ab) for the treatment of adults with moderate to severe hidradenitis suppur=
ativa
------------------------------------------------------------
=C2=B7 Positive CHMP opinion is supported by data from the two Phase 3 stud=
ies, BE HEARD I and BE HEARD II, where bimekizumab showed clinically meanin=
gful improvements vs. placebo at Week 16 which were sustained to Week 48
=C2=B7 If approved by the European Commission, bimekizumab would be the fir=
st biologic for moderate to severe hidradenitis suppurativa to target IL-17=
F in addition to IL-17A=C2=A0
=C2=B7 Hidradenitis suppurativa is one of the most burdensome, chronic, inf=
lammatory skin diseases that has a profound impact on patients=E2=80=99 hea=
lth-related quality of life, and for which there are currently few approved=
treatment options
=C2=A0
Brussels (Belgium), 22 March 2024 =E2=80=93 07:00 (CET) =E2=80=93 UCB, a gl=
obal biopharmaceutical company, today=C2=A0announced that the Committee for=
Medicinal Products for Human Use (CHMP) of the European Medicines Agency (=
EMA) has issued a positive opinion recommending granting marketing authoriz=
ation for BIMZELX^=C2=AE (bimekizumab) in the European Union (EU)/European =
Economic Area (EEA) for the treatment of active moderate to severe hidraden=
itis suppurativa (HS; acne inversa) in adults with an inadequate response t=
o 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.
=E2=80=9CThe positive opinion from the CHMP represents a significant milest=
one toward bringing bimekizumab to people living with moderate to severe hi=
dradenitis suppurativa, a chronic, painful inflammatory skin disease with l=
imited treatment options,=E2=80=9D said Emmanuel Caeymaex, Executive Vice P=
resident, Immunology Solutions, and Head of U.S., UCB. =C2=A0=E2=80=9CIf ap=
proved by the European Commission, this would represent the fourth marketin=
g authorization for bimekizumab in three years, adding to the existing indi=
cations in moderate to severe plaque psoriasis, active psoriatic arthritis =
and active axial spondyloarthritis.=E2=80=9D=C2=A0
=C2=A0
HS is a chronic inflammatory skin disease that manifests as nodules, absces=
ses and pus-discharging fistulas, i.e., channels leading out of the skin, t=
ypically in the armpits, groin, and buttocks.^1 HS affects approximately on=
e percent of the population in most studied countries with those affected e=
xperiencing flare-ups of the disease as well as severe pain.^1,2,3=C2=A0 Pe=
ople 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=C2=A0
The CHMP positive opinion for bimekizumab is based on findings from the Pha=
se 3 BE HEARD I and BE HEARD II studies which evaluated the efficacy and sa=
fety of bimekizumab in the treatment of adults with moderate to severe HS.^=
4,5=C2=A0 Data showed that bimekizumab treatment resulted in statistically =
significant and clinically meaningful improvements over placebo in the sign=
s and symptoms of HS, as measured by HiSCR50 at Week 16, the primary endpoi=
nt, with responses sustained to Week 48.^4,5 Bimekizumab treatment also res=
ulted in improvements over placebo in the high threshold endpoint, HiSCR75 =
at Week 16, a key ranked secondary endpoint, with responses sustained to We=
ek 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=C2=A0
The CHMP positive opinion on bimekizumab in moderate to severe HS will be r=
eferred 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 eff=
icacy and safety of bimekizumab in adults with moderate to severe hidradeni=
tis 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 endpoi=
nt in both studies was HiSCR50 at Week 16.^4,5 A key ranked secondary endpo=
int 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 dr=
aining tunnel count.^4,5
About BIMZELX^=C2=AE (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.^6 The therapeutic indic=
ations in the European Union are:^7
=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.^7=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).^7=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.^7=C2=A0
BIMZELX^=C2=AE (bimekizumab) EU/EEA* Important Safety Information^7
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 and fatigue. Elderly individual=
s may be more likely to experience certain adverse reactions such as oral c=
andidiasis, dermatitis 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 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 (https://u7061146.ct.=
sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rC2tJ60H3Fdk1VajTAIAj=
7NPJeYj-2Ba-2BL1r-2B0jLM-2FtfvSeD3KLQsazq58-2BxwfyV7LSQd4uSQwA6JMudpi5XOwHZ=
tyAHZJBd6YRdp1RSNV5wqOW-2B2nuMhJvPUY2IJDXRoqHUQ-3D-3DiDTD_2dCLUNbuBjhX746-2=
FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3=
MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33bmOTT4LtKtILLAgjlSzidGq5pfvIr=
ElAmFCJi75egfAudmPkzxR-2FgEZTHLQ1mQAC7CXybuA7MypxYhMKhmSc6LfKxuFU3OmB8cSoFf=
rdyKTMHq2R-2BzjiFYpl8ua6zQQnEQaoOTM1heEy-2Bq57MwGJDloyb2G32aaPVQW59IiPmUhAL=
T6hH4mVsJbrqGLt2xIXRb-2BDtzIjMRMo0BRxdYQlkWegCpzXLz45JZ8oyy6NYZ0-3D in rela=
tion to other side effects, full safety and prescribing information.^7=C2=
=A0
European SmPC date of revision: November 2023.=C2=A0
Last accessed: March 2024.
*EU/EEA means European Union/European Economic Area
=E2=96=BCThis medicinal product is subject to additional monitoring. This w=
ill allow quick identification of new safety information. Healthcare profes=
sionals 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=
ed legal, arbitration, political, regulatory or clinical results or practic=
es and other such estimates and results. By their nature, such forward-look=
ing statements are not guarantees of future performance and are subject to =
known and unknown risks, uncertainties and assumptions which might cause th=
e actual results, financial condition, performance or achievements of UCB, =
or industry results, to differ materially from those that may be expressed =
or implied by such forward-looking statements contained in this press relea=
se. Important factors that could result in such differences include: change=
s in general economic, business and competitive conditions, the inability t=
o obtain necessary regulatory approvals or to obtain them on acceptable ter=
ms or within expected timing, costs associated with research and developmen=
t, changes in the prospects for products in the pipeline or under developme=
nt by UCB, effects of future judicial decisions or governmental investigati=
ons, safety, quality, data integrity or manufacturing issues; potential or =
actual data security and data privacy breaches, or disruptions of our infor=
mation technology systems, product liability claims, challenges to patent p=
rotection for products or product candidates, competition from other produc=
ts including biosimilars, changes in laws or regulations, exchange rate flu=
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=
, will progress to product approval or that new indications for existing pr=
oducts will be developed and approved. Movement from concept to commercial =
product is uncertain; preclinical results do not guarantee safety and effic=
acy of product candidates in humans. So far, the complexity of the human bo=
dy cannot be reproduced in computer models, cell culture systems or animal =
models. The length of the timing to complete clinical trials and to get reg=
ulatory approval for product marketing has varied in the past and UCB expec=
ts similar unpredictability going forward. Products or potential products, =
which are the subject of partnerships, joint ventures or licensing collabor=
ations may be subject to differences disputes between the partners or may p=
rove to be not as safe, effective or commercially successful as UCB may hav=
e believed at the start of such partnership. UCB=E2=80=99s efforts to acqui=
re other products or companies and to integrate the operations of such acqu=
ired companies may not be as successful as UCB may have believed at the mom=
ent of acquisition. Also, UCB or others could discover safety, side effects=
or manufacturing problems with its products and/or devices after they are =
marketed. The discovery of significant problems with a product similar to o=
ne of UCB=E2=80=99s products that implicate an entire class of products may=
have a material adverse effect on sales of the entire class of affected pr=
oducts. Moreover, sales may be impacted by international and domestic trend=
s toward managed care and health care cost containment, including pricing p=
ressure, political and public scrutiny, customer and prescriber patterns or=
practices, and the reimbursement policies imposed by third-party payers as=
well as legislation affecting biopharmaceutical pricing and reimbursement =
activities and outcomes. Finally, a breakdown, cyberattack or information s=
ecurity breach could compromise the confidentiality, integrity and availabi=
lity of UCB=E2=80=99s data and systems.=C2=A0
Given these uncertainties, you should not place undue reliance on any of su=
ch forward-looking statements. There can be no guarantee that the investiga=
tional or approved products described in this press release will be submitt=
ed or approved for sale or for any additional indications or labelling in a=
ny market, or at any particular time, nor can there be any guarantee that s=
uch products will be or will continue to be commercially successful in the =
future.
UCB is providing this information, including forward-looking statements, on=
ly as of the date of this press release. UCB expressly disclaims any duty t=
o update any information contained in this press release, either to confirm=
the actual results or to report or reflect any change in its forward-looki=
ng statements with regard thereto or any change in events, conditions or ci=
rcumstances on which any such statement is based, unless such statement is =
required pursuant to applicable laws and regulations.=C2=A0
Additionally, information contained in this document shall not constitute a=
n 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 jurisdi=
ction in which such offer, solicitation or sale would be unlawful prior to =
the registration or qualification under the securities laws of such jurisdi=
ction.=C2=A0
References
1. =C2=A0 Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. =
Nat Rev Dis Primers. 2020;6(1):18.
2. =C2=A0 Koumaki D, Efthymiou O, Bozi E, et al. Perspectives On Perceived =
Stigma And Self-Stigma In Patients With Hidradenitis Suppurativa. Clin Cosm=
et Investig Dermatol. 2019;12(1):785=E2=80=9390.
3. =C2=A0 Kokolakis G, Wolk K, Schneider-Barrus S, et al. Delayed Diagnosis=
of Hidradenitis Suppurativa and Its Effect on Patients and Healthcare Syst=
em. Dermatology. 2020;236(5):421=E2=80=9330.
4. =C2=A0 Kimball AB, Zouboulis CC, Sayed C, et al. Bimekizumab in patients=
with moderate-to-severe hidradenitis suppurativa: 48-week =C2=A0 efficacy =
and safety from BE HEARD I & II, two phase 3, randomized, double-blind, pla=
cebo controlled, multicenter studies. Late-Breaking Platform Presentation a=
t the American Academy of Dermatology Congress 2023.
5. =C2=A0 Zouboulis C. 2023 EADV. Session S042-45981.
6. =C2=A0 Glatt S, Helmer E, Haier B, et al. First-in-human randomized stud=
y of bimekizumab, a humanized monoclonal antibody and selective dual inhibi=
tor of IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5=
):991=E2=80=931001.
7. =C2=A0 BIMZELX^=C2=AE (bimekizumab) EU SmPC. https://u7061146.ct.sendgri=
d.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rC2tJ60H3Fdk1VajTAIAj7NPJeYj=
-2Ba-2BL1r-2B0jLM-2FtfvSeD3KLQsazq58-2BxwfyV7LSQd4uSQwA6JMudpi5XOwHZtyAHZJB=
d6YRdp1RSNV5wqOWwE2cRsny7Ehx4x7oG7pgXg-3D-3DW27Q_2dCLUNbuBjhX746-2FvM63L9Hy=
n3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93=
DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33bmOTT4LtKtILLAgjlSzidGq5pfvIrElAmFCJi7=
5egfAudmPkzxR-2FgEZTHLQ1mQAC7CXybuA7MypxYhMKhmSc6DAOQSppbaseUa94Z-2FfDjiAG0=
GpD6Zkq60hZ0uqIzbOWDpt6J93-2B7bsilu3DaQe-2BCW0s1cW5w2roCXFKkVhk-2BoDGgJzAVY=
3Yx0djVY544pIBrS8BOu28uxo9O-2BJ4frXZ-2Ffo2gx94SwGtqzjFgFGG65o-3D Accessed M=
arch 2024.
GenericFile
UCB PR BKZ CHMP HS March 22 2024 ENG (https://u7061146.ct.sendgrid.net/ls/c=
lick?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rCyBv9bezcPT-2BuItTLKIHepa9dM6LtSZwZtI=
PkR6SL5H12zt-2FRTowIH48R0NyyYWCQ9o3L-2BTAo7NTg82EY-2BwZMDQ-3DcVEl_2dCLUNbuB=
jhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ=
4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33bmOTT4LtKtILLAgjlSzid=
Gq5pfvIrElAmFCJi75egfAudmPkzxR-2FgEZTHLQ1mQAC7CXybuA7MypxYhMKhmSc6IsOT-2BaF=
mLg7SkDUcmb5VxoDtrwKmWDVRSfIcxDkWC56gGuQ3-2FAMyMX0tHFZUjmcBE8rkwDXq-2Bih3RM=
XIGyDFgKTvEMTi8Yb2NczxoKvje0GkFTyNNjegh8PV2DCTDu7wMXFgRVo-2BRrBHsom-2Bk5FMz=
I-3D
______________________
If you would rather not receive future communications from UCB SA, please g=
o to https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIu=
Sly0rC3nfmD42E6tJ6HwHGmqtXbhtXDlQ2cTEdRpWV-2BrYPIUN4zCUWMF-2FgJTTuKp5k2gmqs=
2hTkzstCtqmKY9-2FNBzsHQz1LGun2oW8zoM-2BTagGFO6pHxkMl-2BezehCNEU-2BOFz-2Bvco=
1FyZTvc9PKTQNQpp89yI-3DAr3a_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl=
-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEG=
LNn-2B6FohpNoV33bmOTT4LtKtILLAgjlSzidGq5pfvIrElAmFCJi75egfAudmPkzxR-2FgEZTH=
LQ1mQAC7CXybuA7MypxYhMKhmSc6GqIcc9OVJu35AI9xdcmJGIvsQ-2BeTjAUcXjLFNHCwAw8Wf=
b-2FScRi-2BfiiEK8PkW-2FREZZC6BiV1pivFVj9iksAzjRkAQ4Sta0Nsbk8WVpn2t-2Fiz2psO=
FUHc6R8rJ84Wk3KX40pjCGAQ1o9qEt-2FB2LaWZc-3D
UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . B - 1070 Belgium
25/04/2024 18:00
25/04/2024 07:01
23/04/2024 20:00
22/04/2024 07:01
19/04/2024 20:00
17/04/2024 07:01
12/04/2024 20:00
12/04/2024 18:01
12/04/2024 07:01
11/04/2024 20:01