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** UCB Receives New European Commission Approvals for BIMZELX^=C2=AE=E2=96=
=BC(bimekizumab) for the Treatment of Psoriatic Arthritis and Axial Spondyl=
oarthritis
------------------------------------------------------------
=C2=B7 Bimekizumab is the first and only IL-17A and IL-17F inhibitor approv=
ed in the European Union for active psoriatic arthritis (PsA) and active ax=
ial spondyloarthritis (axSpA)
=C2=B7 Approval in PsA is supported by two Phase 3 studies where bimekizuma=
b showed improvements vs. placebo in joint and skin symptoms across biologi=
c na=C3=AFve and TNF inhibitor-inadequate responder populations=C2=A0
=C2=B7 Approval in axSpA is supported by two Phase 3 studies where bimekizu=
mab showed improvements vs. placebo in signs, symptoms and disease activity=
across the spectrum of disease=C2=A0
Brussels (Belgium), 7th June 2023 =E2=80=93 07:00 (CEST) =E2=80=93 UCB, a g=
lobal biopharmaceutical company, today announced that the European Commissi=
on (EC) has granted marketing authorisation for BIMZELX^=C2=AE (bimekizumab=
) for the treatment of adults with active psoriatic arthritis (PsA) and adu=
lts with active axial spondyloarthritis (axSpA) including non-radiographic =
axSpA (nr-axSpA) and ankylosing spondylitis (AS), also known as radiographi=
c axSpA. These approvals in the European Union (EU) represent the first mar=
keting authorizations for bimekizumab in PsA and axSpA worldwide, and the s=
econd and third indications for bimekizumab in the EU, following its approv=
al for the treatment of moderate to severe plaque psoriasis in August 2021.=
^1
=E2=80=9CThe European Commission=E2=80=99s parallel approval of bimekizumab=
in PsA and axSpA builds on the momentum created since its first approval i=
n moderate to severe plaque psoriasis and marks an exciting milestone offer=
ing healthcare professionals and patients the first IL-17A and IL-17F inhib=
itor for treatment of these diseases,=E2=80=9D said Emmanuel Caeymaex, Exec=
utive Vice President, Immunology Solutions and Head of U.S., UCB. =E2=80=9C=
The extended approval for bimekizumab in the European Union reflects our co=
mmitment to address unmet patient needs, improve patient outcomes and raise=
standards of care.=E2=80=9D =C2=A0
In PsA, bimekizumab is approved alone or in combination with methotrexate f=
or the treatment of adults who have had an inadequate response or who have =
been intolerant to one or more disease-modifying antirheumatic drugs (DMARD=
s).^1 In axSpA, bimekizumab is approved for the treatment of adults with ac=
tive nr-axSpA with objective signs of inflammation as indicated by elevated=
C-reactive protein and/or magnetic resonance imaging who have responded in=
adequately or are intolerant to non-steroidal anti-inflammatory drugs, and =
for the treatment of adults with active AS who have responded inadequately =
or are intolerant to conventional therapy.^1
Bimekizumab in PsA: Highlights from BE OPTIMAL and BE COMPLETE
The EC approval in PsA is based on results from the Phase 3 BE OPTIMAL and =
BE COMPLETE studies.^1,2,3=C2=A0 In the two studies, bimekizumab met the pr=
imary endpoint of ACR50 response at Week 16 vs. placebo, and all ranked sec=
ondary endpoints.^1,2,3 Consistent results were seen across both biologic-n=
a=C3=AFve and TNF-inhibitor inadequate responder (TNFi-IR) populations.^1 2=
,3 Clinical responses achieved at Week 16 were sustained up to Week 52 in B=
E OPTIMAL as assessed by ACR50, PASI90, PASI100 and Minimal Disease Activit=
y (MDA).^1=C2=A0
=C2=B7 Joint Symptoms, ACR50: In bDMARD-naive and TNFi-IR patients, 44 perc=
ent (n=3D189/431) and 43 percent (n=3D116/267) receiving bimekizumab achiev=
ed the primary endpoint of ACR50 response at Week 16, respectively, vs. 10 =
percent (n=3D28/281) and 7 percent (n=3D9/133) receiving placebo (p<0.0001)=
.^2,3=C2=A0
=C2=B7 MDA: In bDMARD-naive and TNFi-IR populations, 45 percent (n=3D194/43=
1) and 44 percent (n=3D118/267) of patients receiving bimekizumab achieved =
the ranked secondary endpoint MDA at Week 16, respectively, vs. 13 percent =
(n=3D37/281) and 6 percent (n=3D8/133) receiving placebo (p<0.0001).^2,3 =
=C2=A0
=C2=B7 Skin Symptoms, PASI100: In bDMARD-naive and TNFi-IR populations, 47 =
percent (n=3D103/176) and 59 percent (n=3D103/176) of patients with baselin=
e psoriasis affecting =E2=89=A53 percent body surface area receiving bimeki=
zumab achieved complete skin clearance (PASI100; exploratory endpoint) at W=
eek 16, respectively, vs. 2 percent (n=3D3/140) and 5 percent (n=3D4/88) re=
ceiving placebo.^2,3 =C2=A0
=E2=80=9CThe approval of bimekizumab in psoriatic arthritis provides rheuma=
tologists and dermatologists in the European Union with a new treatment opt=
ion. Data from the Phase 3 clinical studies demonstrated the consistently h=
igh thresholds of disease control achieved with bimekizumab vs. placebo in =
patients with psoriatic arthritis who were biologic na=C3=AFve or TNF inhib=
itor-inadequate responders,=E2=80=9D said Professor Iain McInnes, Universit=
y of Glasgow, College of Medical, Veterinary and Life Sciences, Glasgow, Sc=
otland.=C2=A0
In BE OPTIMAL, the most frequent treatment-emergent adverse events (TEAEs; =
3 percent or more) for patients on bimekizumab up to Week 16 were nasophary=
ngitis, upper respiratory tract infection, headache, diarrhoea, oral candid=
iasis, pharyngitis and hypertension.^2 In BE COMPLETE, the most frequent TE=
AEs (2 percent or more) for patients on bimekizumab up to Week 16 were naso=
pharyngitis, oral candidiasis and upper respiratory tract infection.^3
Bimekizumab in axSpA: Highlights from BE MOBILE 1 and BE MOBILE 2
The EC approval in axSpA is based on results from the Phase 3 BE MOBILE 1 a=
nd BE MOBILE 2 studies.^1,4=C2=A0 In the two studies, bimekizumab met the p=
rimary endpoint of Assessment of SpondyloArthritis international Society (A=
SAS) 40 response at Week 16 vs. placebo, and all ranked secondary endpoints=
.^4 ASAS40 responses were consistent across TNFi-na=C3=AFve and TNFi-inadeq=
uate responder patients.^4 Clinical responses achieved at Week 16 were sust=
ained in both nr-axSpA and AS patient populations up to Week 52 as assessed=
by ASAS40 and other endpoints.^1,5
=C2=B7 ASAS40: In nr-axSpA and AS populations, 47.7 percent (n=3D61/128) an=
d 44.8 percent (n=3D99/221) respectively of patients receiving bimekizumab =
achieved the primary endpoint of ASAS40 response at Week 16, vs. 21.4 perce=
nt (n=3D27/126) and 22.5 percent (n=3D25/111) receiving placebo (p<0.001).^=
4=C2=A0
=C2=B7 Low Disease Activity: Low disease activity (ASDAS<2.1 combining ASDA=
S-Inactive Disease and ASDAS-Low Disease, an exploratory endpoint) was achi=
eved at Week 16 by 46.2 percent of nr-axSpA patients and 44.9 percent of AS=
patients vs. 20.6 percent and 17.5 percent in the placebo group.^4 In the =
two studies, approximately 6 out of 10 patients treated with bimekizumab ac=
hieved ASDAS<2.1 at Week 52.^1
=C2=B7 Inflammation: Sustained reduction of objective inflammatory signs in=
both sacroiliac joints and the spine was observed in nr-axSpA and AS patie=
nts treated with bimekizumab vs. placebo as assessed by magnetic resonance =
imaging at Week 16 and Week 52, an exploratory endpoint.^4,5=C2=A0
In addition, in pooled data from BE MOBILE 1 and BE MOBILE 2, at Week 16, t=
he proportion of patients developing a uveitis event was lower with bimekiz=
umab (0.6 per cent) compared to placebo (4.6 percent). The incidence of uve=
itis remained low with long-term treatment with bimekizumab (1.2/100 patien=
t-years in the pooled Phase 2/3 studies).^1
=E2=80=9CToday=E2=80=99s approval of a new treatment option for axial spond=
yloarthritis is welcome news to the European rheumatology community. In pha=
se 3 clinical studies a greater proportion of patients treated with bimekiz=
umab, compared with placebo, achieved high treatment targets with significa=
nt improvement in signs, symptoms and measures of disease activity across t=
he full spectrum of disease, including non-radiographic and radiographic po=
pulations,=E2=80=9D said Professor D=C3=A9sir=C3=A9e van der Heijde, Profes=
sor of Rheumatology, Leiden University Medical Center, Leiden, the Netherla=
nds.=C2=A0
The most frequently reported TEAEs (3 percent or more in any bimekizumab gr=
oup in either trial) up to Week 16 were nasopharyngitis, upper respiratory =
tract infection, pharyngitis, diarrhoea, headache and oral candidiasis.^4=
=C2=A0
Notes to editors:
About BE OPTIMAL and BE COMPLETE
The safety and efficacy of bimekizumab (160 mg every four weeks) were evalu=
ated in adult patients with active psoriatic arthritis (PsA) in two multice=
ntre, randomized, double-blind, placebo-controlled studies (BE OPTIMAL and =
BE COMPLETE).^1,2,3 =C2=A0The BE OPTIMAL study evaluated 852 patients not p=
reviously exposed to any biologic disease-modifying anti-rheumatic drug (bD=
MARD-na=C3=AFve) for the treatment of psoriasis or psoriatic arthritis.^2 T=
he BE COMPLETE study evaluated 400 patients with an inadequate response or =
intolerance to treatment with one or two tumour necrosis factor alpha inhib=
itors (TNFi-IR) for either psoriatic arthritis or psoriasis.^3 Detailed fin=
dings from the BE OPTIMAL and BE COMPLETE studies are published in The Lanc=
et.^2,3=C2=A0
About BE MOBILE 1 and BE MOBILE 2
The efficacy and safety of bimekizumab (160 mg every four weeks) were evalu=
ated in 586 adult patients with active axial spondyloarthritis (axSpA) in t=
wo multicenter, randomized, double-blind, placebo-controlled studies, one i=
n non-radiographic axSpA (nr-axSpA; BE MOBILE 1) and one in ankylosing spon=
dylitis (AS; BE MOBILE 2), also known as radiographic axSpA.^1,4 The BE MOB=
ILE 1 and BE MOBILE 2 studies evaluated 254 and 332 patients, respectively.=
^4 Detailed findings from the BE MOBILE 1 and BE MOBILE 2 studies are publi=
shed in the Annals of the Rheumatic Diseases.^4=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.^1,6=C2=A0 The therapeut=
ic indications 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.^1=C2=A0
=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).^1=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 th=
e treatment of adults with active ankylosing spondylitis who have responded=
inadequately or are intolerant to conventional therapy.^1=C2=A0
BIMZELX^=C2=AE =E2=96=BC=C2=A0(bimekizumab) EU/EEA* Important Safety Inform=
ation^1
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 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: June 2023.
https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-pro=
duct- information_en.pdf (https://www.ema.europa.eu/en/documents/product-in=
formation/bimzelx-epar-product-information_en.pdf)
*EU/EEA means European Union/European Economic Area
=E2=96=BC This medicinal product is subject to additional monitoring. This =
will allow quick identification of new safety information. Healthcare profe=
ssionals 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.
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lity of UCB=E2=80=99s data and systems.=C2=A0
Given these uncertainties, you should not place undue reliance on any of su=
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References
1. BIMZELX^=C2=AE (bimekizumab) EU Summary of Product Characteristics. Avai=
lable at: =C2=A0
https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-pro=
duct-information_en.pdf.
2. McInnes IB, Asahina A, Coates LC, et al. Bimekizumab in patients with ps=
oriatic arthritis, na=C3=AFve to biologic treatment: a randomised, double-b=
lind, placebo-controlled, phase 3 trial (BE OPTIMAL). Lancet. 2023;401(1037=
0):25=E2=80=9337.
3. Merola JF, Landew=C3=A9 R, McInnes IB, et al. Bimekizumab in patients wi=
th active psoriatic arthritis and previous inadequate response or intoleran=
ce to tumour necrosis factor-=CE=B1 inhibitors: a randomised, double-blind,=
placebo-controlled, phase 3 trial (BE COMPLETE). Lancet. 2023;401(10370):3=
8=E2=80=9348.
4. Van der Heijde D, Deodhar A, Baraliakos X, et al. Efficacy and safety of=
bimekizumab in axial spondyloarthritis: results of two parallel phase 3 ra=
ndomized controlled trials. Ann Rheum Dis Published Online First: January 2=
023. doi:10.1136/ard-2022-223595 (https://ard.bmj.com/content/early/2023/01=
/16/ard-2022-223595) . Last accessed: June 2023.
5. Baraliakos X, Deodhar A, van der Heijde D, et al. Bimekizumab maintains =
improvements in efficacy endpoints and has a consistent safety profile thro=
ugh 52 weeks in patients with non-radiographic axial spondyloarthritis and =
ankylosing spondylitis: results from two parallel Phase 3 studies. Arthriti=
s Rheumatol. 2022;74(suppl 9).
6. Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bi=
mekizumab, a humanized monoclonal =C2=A0 =C2=A0antibody and selective dual =
inhibitor of IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 201=
7;83(5):991-1001.
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