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** BIMZELX^=C2=AE=E2=96=BC (bimekizumab) Receives First Positive Health Tec=
hnology Assessment Worldwide
------------------------------------------------------------
=C2=B7 The UK=E2=80=99s National Institute for Health and Care Excellence p=
ublished its final Technology Appraisal Guidance recommending bimekizumab a=
s a treatment option for adults with severe plaque psoriasis=C2=A0
=C2=B7 This first positive health technology assessment worldwide recognize=
s the value that bimekizumab can bring to patients, healthcare systems and =
societies=C2=A0
Brussels, Belgium =E2=80=93 6th September 2021 =E2=80=93 0700 CEST =E2=80=
=93 UCB, a global biopharmaceutical company, today announced that the Natio=
nal Institute for Health and Care Excellence (NICE), the UK health technolo=
gy assessment body that appraises new medicines for use in England and Wale=
s, has published its final Technology Appraisal Guidance (TAG) recommending=
BIMZELX^=C2=AE (bimekizumab) as a treatment option for adults with severe =
plaque psoriasis who have not responded to other systemic treatments, or if=
these treatments are contraindicated, or not tolerated.^1=C2=A0This positi=
ve guidance is the outcome of the first health technology assessment for bi=
mekizumab worldwide.
=E2=80=9CThe positive health technology assessment by NICE recognizes the v=
alue that bimekizumab can bring to patients, to healthcare systems and to s=
ocieties, and is underpinned by UCB=E2=80=99s commitment to ensuring access=
to our innovative medicines in a timely manner,=E2=80=9D said Emmanuel Cae=
ymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB=
. =E2=80=9CWe are delighted with the speed in which bimekizumab could be av=
ailable to psoriasis patients in England and Wales, and support NICE=E2=80=
=99s appraisal of our new psoriasis treatment option.=E2=80=9D
=C2=A0
Bimekizumab is the first medicine to be evaluated and recommended through N=
ICE=E2=80=99s new Expedited Low-Risk Fast Track Appraisal, and National Hea=
lth Service (NHS) funding for bimekizumab could be available in England and=
Wales within approximately one month.^1=C2=A0
NICE made its recommendations based on a submission that included efficacy =
and safety data from the bimekizumab Phase 3 clinical program in psoriasis.=
^1 It considered that evidence from these trials showed that bimekizumab wa=
s more effective than adalimumab, secukinumab and ustekinumab.^1 NICE also =
concluded that indirect comparisons suggested that bimekizumab was similarl=
y or more effective than other biological treatments, including risankizuma=
b, brodalumab and ixekizumab.^1=C2=A0
Further health technology assessments of bimekizumab are underway in countr=
ies in the European Union (EU), with decisions anticipated later in the yea=
r.=C2=A0
In August 2021, bimekizumab received marketing authorization in Great Brita=
in,^2=C2=A0and in countries of the EU,^3 for the treatment of moderate to s=
evere plaque psoriasis in adults who are candidates for systemic therapy.=
=C2=A0
Notes to Editors:=C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =
=C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=
=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0=C2=A0
About BIMZELX (bimekizumab)=C2=A0
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.^3=C2=A0Elevated conc=
entrations of IL-17A and IL-17F have been implicated in the pathogenesis of=
several immune-mediated inflammatory diseases including plaque psoriasis.^=
3 Bimekizumab inhibits these proinflammatory cytokines, resulting in the no=
rmalization of skin inflammation and, as a consequence, improvement in clin=
ical symptoms associated with psoriasis.^3
Bimzelx^=C2=AE=E2=96=BC (bimekizumab) EU/EEA* Important Safety Information
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 Europe=
an 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/documents/product-information/bimzelx-epar-product-information_en.=
pdf=C2=A0
Last accessed: September 2021.
=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.=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.
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, =
=E2=80=9Canticipates=E2=80=9D, =E2=80=9Cexpects=E2=80=9D, =E2=80=9Cintends=
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UCB is providing this information, including forward-looking statements, on=
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UCB is following the worldwide developments diligently to assess the financ=
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For further information, contact UCB:=C2=A0
Corporate Communications
Laurent Schots=C2=A0
Media Relations, UCB =C2=A0
T+32.2.559.92.64 =C2=A0Laurent.schots@ucb.com=C2=A0
Investor Relations
Antje Witte =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0
Investor Relations, UCB
T +32.2.559.94.14 antje.witte@ucb.com
Brand Communications
Eimear O=E2=80=99Brien,=C2=A0
Brand Communications, UCB
T + 32.2.559.92.71 eimear.obrien@ucb.com =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0=
=C2=A0 =C2=A0 =C2=A0 =C2=A0
=C2=A0=C2=A0 =C2=A0
References
1. NICE Technology Appraisal Guidance. Bimekizumab for treating moderate to=
severe plaque psoriasis. https://www.nice.org.uk/guidance/ta723 Last acces=
sed September 2021=C2=A0
2. BIMZELX (bimekizumab) GB Summary of Product Characteristics https://bit.=
ly/Bimzelx-SmPC-Pre-filled-Syringe =C2=A0https://bit.ly/Bimzelx-SmPC-Pre-fi=
lled-Pen. Last accessed September 2021
3. BIMZELX (bimekizumab) EU Summary of Product Characteristics https://www.=
ema.europa.eu/en/documents/product-information/bimzelx-epar-product-informa=
tion_en.pdf. Last accessed September 2021
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