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** European Medicine Agency Accepts Marketing Authorization Applications fo=
r Bimekizumab in Psoriatic Arthritis and Axial Spondyloarthritis
------------------------------------------------------------
=C2=B7 First regulatory submissions for bimekizumab in psoriatic arthritis =
and axial spondyloarthritis worldwide
Brussels (Belgium), 20th September 2022 =E2=80=93 07:00 (CEST) =E2=80=93 UC=
B, a global biopharmaceutical company, today announced that the European Me=
dicines Agency (EMA) has accepted for regulatory review the two marketing a=
uthorization applications for bimekizumab for the treatment of adult patien=
ts with active psoriatic arthritis (PsA), and adult patients with active ax=
ial spondyloarthritis (axSpA).
=E2=80=9CThese two regulatory applications in psoriatic arthritis and axial=
spondyloarthritis represent a significant milestone for bimekizumab as wel=
l as an important step towards expanding treatment options in the EU for th=
ese debilitating conditions. If approved for these two new indications, bim=
ekizumab would be the first new treatment option in psoriatic arthritis and=
axial spondyloarthritis to selectively target IL-17F, in addition to IL-17=
A,=E2=80=9D said Emmanuel Caeymaex, Executive Vice President, Immunology So=
lutions and Head of U.S., UCB.
The application in PsA is supported by data from the Phase 3 BE OPTIMAL and=
BE COMPLETE studies.^1,2=C2=A0 In both studies, bimekizumab met the primar=
y and all ranked secondary endpoints, achieving clinically relevant improve=
ments over placebo in both joint and skin symptoms, with efficacy outcomes =
consistent across the biologic-na=C3=AFve and TNF-inhibitor inadequate resp=
onder (TNFi-IR) populations.^1,2 The application in active axSpA is based o=
n data from the Phase 3 BE MOBILE 1 study in non-radiographic axSpA and the=
Phase 3 BE MOBILE 2 study in ankylosing spondylitis.^3,4=C2=A0 Bimekizumab=
met the primary and all ranked secondary endpoints in both studies showing=
consistent improvements versus placebo in signs and symptoms across the fu=
ll spectrum of axSpA, including non-radiographic axSpA and ankylosing spond=
ylitis.3,4 Across all four Phase 3 studies the safety profile of bimekizuma=
b was consistent with safety data seen in previous studies with no new obse=
rved safety signals.^1,2,3,4=C2=A0
In August 2021, bimekizumab received marketing authorization in countries o=
f the European Union (EU)/European Economic Area (EEA) for the treatment of=
moderate to severe plaque psoriasis in adults who are candidates for syste=
mic therapy.^5 The safety and efficacy of bimekizumab in PsA and axSpA have=
not been established, and it is not approved for use in PsA or axSpA by an=
y regulatory authority worldwide.
Notes to editors:
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a serious, highly heterogeneous, chronic, syst=
emic inflammatory condition affecting both the joints and skin, with a prev=
alence of 0.02 percent to 0.25 percent of the population, and 6 percent to =
41 percent of patients with psoriasis.^6 Symptoms include joint pain and st=
iffness, skin plaques, swollen toes and fingers (dactylitis), and inflammat=
ion of the sites where tendons or ligaments insert into the bone (enthesiti=
s).^7
About Axial Spondyloarthritis
Axial Spondyloarthritis (axSpA), which includes both non-radiographic axSpA=
(nr-axSpA) and ankylosing spondylitis (AS), also known as radiographic axS=
pA (r-axSpA), is a chronic, immune-mediated, inflammatory disease.^8 nr-axS=
pA is defined clinically by the absence of definitive x-ray evidence of str=
uctural damage to the sacroiliac joints.^8 AxSpA is a painful condition tha=
t primarily affects the spine and joints linking the pelvis and lower spine=
(sacroiliac joints).^8 The leading symptom of axSpA in the majority of pat=
ients is inflammatory back pain that improves with exercise, but not with r=
est.^8 Other common clinical features include anterior uveitis, enthesitis,=
peripheral arthritis, psoriasis, inflammatory bowel disease and dactylitis=
.^8 The overall prevalence of axSpA is 0.3 percent to 1.3 percent of adults=
.^9,10 Approximately half of all patients with axSpA are patients with nr-a=
xSpA.8 axSpA onset usually occurs before the age of 45.8 Approximately 10 t=
o 40 percent of patients with nr-axSpA progress to ankylosing spondylitis o=
ver 2 to 10 years.^8
About BE OPTIMAL
BE OPTIMAL is a randomized, multicenter, double-blind, placebo-controlled, =
active reference (adalimumab), parallel-group, Phase 3 study designed to ev=
aluate the efficacy and safety of bimekizumab in the treatment of adult pat=
ients with active PsA, who are biologic disease-modifying anti rheumatic dr=
ug na=C3=AFve. For additional details on the study, visit BE OPTIMAL on cli=
nicaltrials.gov (https://www.clinicaltrials.gov/ct2/show/NCT03895203?term=
=3DBE+OPTIMAL&draw=3D2&rank=3D1) .^11
About BE COMPLETE
BE COMPLETE was a randomized, multicenter, double-blind, placebo-controlled=
, parallel-group, Phase 3 study designed to evaluate the efficacy and safet=
y of bimekizumab in adults with active PsA and an inadequate response to tu=
mor necrosis factor inhibitors (TNFi-IR).^12 All enrolled study participant=
s had a history of inadequate response (lack of efficacy after at least thr=
ee months of therapy at an approved dose) or intolerance to treatment with =
one or two TNFi for either PsA or psoriasis. For additional details on the =
study, visit BE COMPLETE on clinicaltrials.gov (https://www.clinicaltrials.=
gov/ct2/show/NCT03896581) .^12
About BE MOBILE 1 =C2=A0 =C2=A0
BE MOBILE 1 is a randomized, multicenter, double-blind, placebo-controlled,=
parallel-group, Phase 3 study designed to evaluate the efficacy and safety=
of bimekizumab in the treatment of adult patients with active nr-axSpA. Fo=
r additional details on the study, visit BE MOBILE 1 on clinicaltrials.gov =
(https://clinicaltrials.gov/ct2/show/NCT03928704) .^13
About BE MOBILE 2
BE MOBILE 2 is a randomized, multicenter, double-blind, placebo-controlled,=
parallel-group, Phase 3 study designed to evaluate the efficacy and safety=
of bimekizumab in the treatment of adult patients with active AS. For addi=
tional details on the study, visit BE MOBILE 2 on clinicaltrials.gov (https=
://www.clinicaltrials.gov/ct2/show/NCT03928743) .^14
About BIMZELX^=C2=AE=E2=96=BC(bimekizumab)
BIMZELX=C2=AE (bimekizumab) is a humanized monoclonal IgG1 antibody that is=
designed to selectively inhibit both interleukin 17A (IL-17A) and interleu=
kin 17F (IL-17F), two key cytokines driving inflammatory processes.^5,15 In=
August 2021, bimekizumab was approved in the EU/EEA and Great Britain for =
the treatment of moderate to severe plaque psoriasis in adults who are cand=
idates for systemic therapy.^5,16=C2=A0 In January 2022, bimekizumab receiv=
ed marketing authorization in Japan for the treatment of plaque psoriasis, =
generalized pustular psoriasis and psoriatic erythroderma in patients who a=
re not sufficiently responding to existing treatments.^17=C2=A0 In February=
and March 2022, bimekizumab received marketing authorization in Canada and=
Australia respectively for the treatment of moderate to severe plaque psor=
iasis in adults who are candidates for systemic therapy or phototherapy.^18=
,19
BIMZELX^=C2=AE =C2=A0=E2=96=BC (bimekizumab) EU/EEA Important Safety Inform=
ation in Psoriasis
The most frequently reported adverse reactions with bimekizumab were upper =
respiratory tract infections (14.5 percent) (most frequently nasopharyngiti=
s) and oral candidiasis (7.3 percent). Common adverse reactions (=E2=89=A51=
/100 to <1/10) were oral candidiasis, tinea infections, ear infections, her=
pes simplex infections, oropharyngeal candidiasis, gastroenteritis, follicu=
litis, headache, dermatitis and eczema, acne, injection site reactions, fat=
igue. Elderly may be more likely to experience certain adverse reactions su=
ch as oral candidiasis, 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).=C2=A0
Bimekizumab may increase the risk of infections. Treatment with bimekizumab=
must not be administered in patients with any clinically important active =
infection. Patients treated with bimekizumab should be instructed to seek m=
edical advice if signs or symptoms suggestive of an infection occur. Prior =
to initiating treatment with bimekizumab, patients should be evaluated for =
tuberculosis (TB) infection. Bimekizumab should not be given in patients wi=
th active TB and patients receiving bimekizumab should be monitored for sig=
ns and symptoms of active TB.=C2=A0
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.=C2=A0
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. https://www.ema.euro=
pa.eu/en/documents/product-information/bimzelx-epar-product-information_en.=
pdf
EU summary of product characteristics date of revision March 2022
Last accessed: June 2022
=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=C2=A0
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=C2=A0 =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 8,600 peopl=
e in approximately 40 countries, the company generated revenue of =E2=82=AC=
5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB). Foll=
ow us on Twitter: @UCB_news.
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=C2=A0
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