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** UCB Announces European Commission Approval of BIMZELX^=C2=AE=E2=96=BC (b=
imekizumab) for the Treatment of Adults with Moderate to Severe Plaque Psor=
iasis
------------------------------------------------------------
=C2=B7 BIMZELX^=C2=AE=E2=96=BC(bimekizumab) is the first approved treatment=
for moderate to severe plaque psoriasis that is designed to selectively an=
d directly inhibit both IL-17A and IL-17F
=C2=B7 The approval in the European Union represents the first marketing au=
thorization for UCB=E2=80=99s new psoriasis treatment worldwide
=C2=B7 Approval is supported by three Phase 3 trials where bimekizumab demo=
nstrated superior levels of skin clearance compared to placebo, ustekinumab=
and adalimumab, and was generally well-tolerated=C2=A0
=C2=B7 Bimekizumab is a testament to UCB=E2=80=99s commitment to advancing =
science in immuno-dermatology, addressing unmet needs and improving patient=
outcomes
Brussels, Belgium =E2=80=93 24th August 2021 =E2=80=93 07:00 CEST - UCB, a =
global biopharmaceutical company, today announced that the European Commiss=
ion (EC) has granted marketing authorization for BIMZELX^=C2=AE (bimekizuma=
b) for the treatment of moderate to severe plaque psoriasis in adults who a=
re candidates for systemic therapy.^1=C2=A0Bimekizumab is the first approve=
d treatment in the European Union (EU) for moderate to severe plaque psoria=
sis that is designed to selectively and directly inhibit both IL-17A and IL=
-17F, two key cytokines driving inflammatory processes.^1
Bimekizumab is approved at a recommended dose of 320 mg, administered by tw=
o subcutaneous injections every four weeks to week 16 and every eight weeks=
thereafter.^1 For some patients with a body weight =E2=89=A5120 kg who did=
not achieve complete skin clearance at week 16, 320 mg every 4 weeks after=
week 16 may further improve treatment response.^1
=E2=80=9CThe approval of BIMZELX in Europe is the first marketing authoriza=
tion for this new psoriasis treatment worldwide and represents a landmark m=
oment for the dermatology community and UCB. Our ambition is to transform t=
he lives of people living with severe diseases, and we are incredibly proud=
to bring a new treatment option to people living with moderate to severe p=
laque psoriasis in Europe. We believe that bimekizumab has the potential to=
raise expectations of what psoriasis treatment can deliver.=E2=80=9D said =
Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head =
of US, UCB.=C2=A0
Psoriasis can have a considerable physical and psychological impact on pati=
ents, as well as being detrimental to their quality of life, potentially af=
fecting work, recreation, relationships, family and social life.^2=C2=A0A c=
ross-sectional patient survey showed at least 90 percent of patients with m=
oderate to severe plaque psoriasis place a high value on treatment which pr=
ovides clear skin, a sustained response and rapid onset of action.^3=C2=A0I=
n addition, a real-world study showed that gaining completely clear skin ca=
n make a meaningful difference to the impact psoriasis has on patients=E2=
=80=99 health-related quality of life.^4=C2=A0
=C2=A0
=E2=80=9CIn the pivotal Phase 3 studies patients treated with bimekizumab a=
chieved superior levels of skin clearance compared to those treated with pl=
acebo, adalimumab and ustekinumab, and in the Phase 3b study, treatment wit=
h bimekizumab resulted in greater levels of skin clearance than secukinumab=
. Across studies, about 60 percent of bimekizumab-treated patients achieved=
complete skin clearance at week 16, and this response was maintained for u=
p to a year.=E2=80=9D said Professor Richard Warren, Salford Royal NHS Foun=
dation Trust and The University of Manchester, UK. =E2=80=9CThe approval of=
bimekizumab in the EU provides a welcome new treatment option that may hel=
p more patients with moderate to severe plaque psoriasis to achieve their t=
reatment goals.=E2=80=9D
The European Commission approval follows a positive opinion granted in June=
2021 by the European Medicines Agency=E2=80=99s Committee for Medicinal Pr=
oducts for Human Use. The approval is supported by positive results from th=
ree Phase 3 studies, which evaluated the efficacy and safety of bimekizumab=
in 1,480 patients with moderate to severe plaque psoriasis.^1 Full finding=
s from the Phase 3 BE READY and BE VIVID studies are published in The Lance=
t, and the results of the Phase 3 BE SURE study are published in The New En=
gland Journal of Medicine.^5,6,7=C2=A0
The approval from the European Commission is valid in all 27 member states =
of the EU, as well as Iceland, Liechtenstein, and Norway. Bimekizumab is cu=
rrently under review by the U.S. Food & Drug Administration (FDA) for the t=
reatment of adults with moderate to severe plaque psoriasis. Regulatory rev=
iews are also underway in Australia, Canada, Great Britain and Japan.=C2=A0
Notes to Editors:
About the Phase 3 Psoriasis Clinical Development Program
The efficacy and safety of bimekizumab were evaluated in three Phase 3 stud=
ies, versus placebo and ustekinumab (BE VIVID), versus placebo (BE READY) a=
nd versus adalimumab (BE SURE).^5,6,7 All studies met their co-primary endp=
oints and all ranked secondary endpoints.^5,6,7
Patients treated with bimekizumab achieved superior levels of skin clearanc=
e at week 16, compared to those who received ustekinumab (ranked secondary =
endpoint, BE VIVID; p<0.0001), placebo (co-primary endpoint, BE READY and B=
E VIVID; p<0.0001) and adalimumab (co-primary endpoint, BE SURE; p<0.001), =
as measured by at least a 90 percent improvement in the Psoriasis Area & Se=
verity Index (PASI 90) and an Investigator=E2=80=99s Global Assessment (IGA=
) response of clear or almost clear skin (IGA 0/1).^5,6,7 Clinical response=
s achieved with bimekizumab at week 16 were maintained up to one year in al=
l studies.^5,6,7 The most frequently reported adverse reactions in the clin=
ical studies were upper respiratory tract infections (14.5 percent) (most f=
requently nasopharyngitis) and oral candidiasis (7.3 percent).^1 For additi=
onal information on the bimekizumab Phase 3 clinical trial program, in psor=
iasis, please refer to the peer-reviewed publications and visit www.clinica=
ltrials.gov.
About BIMZELX^=C2=AE (bimekizumab) in the EU
Bimekizumab is a humanized IgG1 monoclonal antibody that selectively binds =
with high affinity to IL-17A, IL-17F and IL-17AF cytokines, blocking their =
interaction with the IL-17RA/IL-17RC receptor complex.^1 Elevated concentra=
tions of IL-17A and IL-17F have been implicated in the pathogenesis of seve=
ral immune-mediated inflammatory diseases including plaque psoriasis.^1 Bim=
ekizumab inhibits these proinflammatory cytokines, resulting in the normali=
zation of skin inflammation and as a consequence improvement in clinical sy=
mptoms associated with psoriasis.^1=C2=A0
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%) (most frequently nasopharyngitis) and =
oral candidiasis (7.3%). Common adverse reactions (=E2=89=A51/100 to <1/10)=
were oral candidiasis, tinea infections, ear infections, herpes simplex in=
fections, oropharyngeal candidiasis, gastroenteritis, folliculitis, headach=
e, dermatitis and eczema, acne, injection site reactions, fatigue. Elderly =
may be more likely to experience certain adverse reactions such as oral can=
didiasis, dermatitis and eczema when using bimekizumab.
*EU/EEA means European Union/European Economic Area
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=C2=A0=C2=A0
=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
=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 8,400 peopl=
e in nearly 40 countries, the company generated revenue of =E2=82=AC5.3 bil=
lion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). Follow us o=
n Twitter: @UCB_news.=C2=A0
Forward looking statements UCB=C2=A0
This press release may contain forward-looking statements including, withou=
t limitation, statements containing the words =E2=80=9Cbelieves=E2=80=9D, =
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ates=E2=80=9D, =E2=80=9Cmay=E2=80=9D, =E2=80=9Cwill=E2=80=9D, =E2=80=9Ccont=
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For further information, contact UCB:=C2=A0
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Corporate Communications
Laurent Schots,=C2=A0
Media Relations, UCB=C2=A0
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Investor Relations, UCB
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References
1. BIMZELX (bimekizumab) EU Summary of Product Characteristics, August 2021=
https://www.ema.europa.eu/en =C2=A0
2. Moon HS, Mizara A, McBride SR. Psoriasis and psycho-dermatology. Dermato=
l Ther (Heidelb). 2013;3(2):117-130.
3. Gorelick J, Shrom D, Sikand K, et al. Understanding Treatment Preference=
s in Patients with Moderate to Severe Plaque Psoriasis in the USA: Results =
from a Cross-Sectional Patient Survey. Dermatol Ther (Heidelb). 2019;9:785-=
797.
4. Lacour J-P, Bewley A, Hammond E, et al. Association Between Patient- and=
Physician-Reported Outcomes in Patients with Moderate-To-Severe Plaque Pso=
riasis Treated with Biologics in Real Life (PSO-BIO-REAL). Dermatol Ther (H=
eidelb). 2020;10:1099-1109.
5. Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for =
the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy a=
nd safety from a 52-week, multicentre, double-blind, active comparator and =
placebo-controlled phase 3 trial. Lancet. 2021;397(10273):487-498.
6. Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety i=
n moderate to severe plaque psoriasis (BE READY): a multicentre, double-bli=
nd, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021;3=
97(10273):475-486.
7. Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus Adalimumab in =
Plaque Psoriasis. N Engl J Med. 2021;385(2):130-141.
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