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** UCB Receives Positive CHMP Opinions for Bimekizumab for the Treatment of=
Adults with Psoriatic Arthritis and Axial Spondyloarthritis in the Europea=
n Union
------------------------------------------------------------
=C2=B7 Positive CHMP opinions are supported by data from four Phase 3 studi=
es that evaluated bimekizumab in active psoriatic arthritis (BE COMPLETE an=
d BE OPTIMAL) and active axial spondyloarthritis (BE MOBILE 1 and BE MOBILE=
2)
=C2=B7 If approved by the European Commission, these would mark the second =
and third indications for bimekizumab
=C2=B7 The European Commission decision is expected within two months
Brussels (Belgium), 27th April 2023 =E2=80=93 07:00 (CET) =E2=80=93 UCB, a =
global biopharmaceutical company, today announced that the Committee for Me=
dicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA=
) has issued positive opinions recommending granting marketing authorizatio=
n for bimekizumab in the European Union (EU) for the treatment of adults wi=
th active axial spondyloarthritis (axSpA) and for adults with active psoria=
tic arthritis (PsA). AxSpA is an indication that spans both non-radiographi=
c axSpA (nr-axSpA) and ankylosing spondylitis (AS), also known as radiograp=
hic axSpA (r-axSpA). If approved by the European Commission (EC), these wou=
ld represent the second and third indications for bimekizumab in the EU, fo=
llowing its initial approval for the treatment of moderate to severe plaque=
psoriasis in adults who are candidates for systemic therapy in August 2021=
.^1=C2=A0=C2=A0
=E2=80=9CThe positive CHMP opinion for two new indications for bimekizumab =
in Europe is a significant step towards our goal of delivering differentiat=
ed treatment options to patients. If approved, bimekizumab would be the fir=
st treatment for psoriatic arthritis and axial spondyloarthritis that inhib=
its IL-17F in addition to IL-17A. Positive results from the four Phase 3 cl=
inical studies in PsA and axSpA showed that treatment with bimekizumab cons=
istently resulted in deep levels of response that were rapid and sustained,=
=E2=80=9D said Emmanuel Caeymaex, Executive Vice President, Immunology Solu=
tions and Head of U.S., UCB.=C2=A0
In active PsA, the CHMP recommended approval of bimekizumab alone or in com=
bination with methotrexate, for the treatment of adults who have had an ina=
dequate response or who have been intolerant to one or more disease-modifyi=
ng antirheumatic drugs. The CHMP opinion is based on data from the Phase 3 =
BE COMPLETE and BE OPTIMAL studies recently published in The Lancet.^2,3=C2=
=A0 The two studies met their primary and all ranked secondary endpoints wi=
th statistical significance at week 16.^2,3 Long-term data from BE OPTIMAL =
showed that bimekizumab demonstrated sustained responses to week 52.^4
In active axSpA, the CHMP recommended approval of bimekizumab for the treat=
ment of adults with active nr-axSpA with objective signs of inflammation as=
indicated by elevated C-reactive protein and/or magnetic resonance imaging=
who have responded inadequately or are intolerant to non-steroidal anti-in=
flammatory drugs, and for the treatment of adults with active AS (r-axSpA) =
who have responded inadequately or are intolerant to conventional therapy. =
The positive CHMP opinion is based on data from the Phase 3 BE MOBILE 1 and=
BE MOBILE 2 studies, recently published in Annals of the Rheumatic Disease=
s.^5 The two studies met their primary and all ranked secondary endpoints w=
ith statistical significance at week 16.^5 Long-term data from both studies=
showed that bimekizumab demonstrated sustained responses to week 52.^6=C2=
=A0
In all four studies (BE OPTIMAL, BE COMPLETE, BE MOBILE 1 and BE MOBILE 2) =
the safety data were consistent with previous studies with no new observed =
safety signals.^2,3,5=C2=A0
The CHMP positive opinions on bimekizumab in active PsA and active axSpA wi=
ll be referred to the EC, which will deliver a final decision within approx=
imately two months. The marketing authorization will be valid in all member=
states of the European Union as well as Iceland, Norway, Northern Ireland =
and Liechtenstein.
Bimekizumab is currently approved in the European Union for the treatment o=
f moderate to severe plaque psoriasis in adults who are candidates for syst=
emic therapy.^1=C2=A0
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.^7 Symptoms include joint pain and st=
iffness, skin plaques, swollen toes and fingers (dactylitis) and inflammati=
on of the sites where tendons or ligaments insert into the bone (enthesitis=
).^8
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.^9 nr-axS=
pA is defined clinically by the absence of definitive x-ray evidence of str=
uctural damage to the sacroiliac joints.^9 axSpA is a painful condition tha=
t primarily affects the spine and the joints linking the pelvis and lower s=
pine (sacroiliac joints).^9 The leading symptom of axSpA in a majority of p=
atients is inflammatory back pain that improves with exercise, but not with=
rest.^9 Other common clinical features frequently include anterior uveitis=
, enthesitis, peripheral arthritis, psoriasis, inflammatory bowel disease a=
nd dactylitis.^9 The overall prevalence of axSpA is 0.3 percent to 1.4 perc=
ent of adults.^10,11=C2=A0Approximately half of all patients with axSpA are=
patients with nr-axSpA.^9 axSpA onset usually occurs before the age of 45.=
^9 Approximately 10 to 40 percent of patients with nr-axSpA progress to AS =
over 2 to 10 years.^9
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.^1,12,13 In August 2021,=
bimekizumab was first approved in the European Union (EU)/European Economi=
c Area (EEA) and in Great Britain, for the treatment of moderate-to-severe =
plaque psoriasis in adults who are candidates for systemic therapy.^1,12 Th=
e label information may differ in other countries where approved. Please ch=
eck local prescribing information.
About BIMZELX^=C2=AE=C2=A0=E2=96=BC(bimekizumab) in the EU/EEA
In the EU/EEA, BIMZELX^=C2=AE is indicated for the treatment of moderate-to=
-severe plaque psoriasis in adults who are candidates for systemic therapy.=
^1=C2=A0
BIMZELX^=C2=AE =E2=96=BC(bimekizumab) EU/EEA Important Safety Information i=
n Psoriasis^1 =C2=A0 =C2=A0
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.
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 December 2022.
Last accessed: April 2023.
=C2=A0=E2=96=BC=C2=A0This medicinal product is subject to additional monito=
ring. This will allow quick identification of new safety information. Healt=
hcare 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
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). Foll=
ow us on Twitter: @UCB_news.
Forward looking statements=C2=A0
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UCB is providing this information, including forward-looking statements, on=
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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. Last accessed: April 2023.
2. 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.
3. 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(103=
70):25=E2=80=9337.=C2=A0
4. Ritchlin C, Coates L, McInnes I, et al. Bimekizumab treatment in biologi=
c DMARD-na=C3=AFve patients with active psoriatic arthritis: 52-week effica=
cy and safety results from a Phase 3, randomized, placebo-controlled, activ=
e reference study. Arthritis Rheumatol. 2022; 74 (suppl 9).=C2=A0
5. 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 =
2023. doi:10.1136/ard-2022-223595 (https://ard.bmj.com/content/early/2023/0=
1/16/ard-2022-223595) . Last accessed: April 2023.=C2=A0
6. 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=
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7. Ogdie A, Weiss P. The epidemiology of psoriatic arthritis. Rheum Dis Cli=
n North Am. 2015;41(4):545=E2=80=93568.=C2=A0
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agnosis and pharmacologic treatment of psoriatic arthritis in patients with=
psoriasis. Drugs. 2014;74(4):423=E2=80=93441.
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are. Am J Manag Care. 2019;25:S319=E2=80=93S330.
10. Reveille J, Witter J, Weisman M. Prevalence of axial spondylarthritis i=
n the United States: estimates from a cross-sectional survey. Arthritis Car=
e Res. 2012;64(6):905=E2=80=93910.
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oarthritis in the UK: a cross-sectional cohort study. BMC Musculoskelet Dis=
ord. 2015;21;16:392.
12. BIMZELX^=C2=AE (bimekizumab) GB Summary of Product Characteristics. Ava=
ilable at: https://www.medicines.org.uk/emc/product/12834/smpc - gref (http=
s://www.medicines.org.uk/emc/product/12834/smpc#gref) . Last accessed: Apri=
l 2023.
13. Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of b=
imekizumab, a humanized monoclonal antibody and selective dual inhibitor of=
IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):991=
=E2=80=931001.
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