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** BIMZELX^=C2=AE Approved by the U.S. FDA for the Treatment of Adults with=
Moderate to Severe Plaque Psoriasis
------------------------------------------------------------
=C2=B7 BIMZELX^=C2=AE (bimekizumab-bkzx) is the first and only IL-17A and I=
L-17F inhibitor approved for the treatment of adults with moderate to sever=
e plaque psoriasis=C2=A0
=C2=B7 Approval is supported by three Phase 3 trials where bimekizumab cons=
istently delivered fast, complete and lasting levels of skin clearance up t=
o one year, and was generally well tolerated
=C2=B7 UCB expects global peak sales for BIMZELX^=C2=AE of at least =E2=82=
=AC4bn
Brussels (Belgium), 18 OCTOBER 2023 =E2=80=93 07:00 (CEST) =E2=80=93 Regula=
ted Information =E2=80=93 Inside Information =E2=80=93 UCB, a global biopha=
rmaceutical company, announced today that the U.S. Food and Drug Administra=
tion (FDA) has approved BIMZELX^=C2=AE (bimekizumab-bkzx) for the treatment=
of moderate to severe plaque psoriasis in adults who are candidates for sy=
stemic therapy or phototherapy. =C2=A0Bimekizumab is the first and only app=
roved psoriasis treatment designed to selectively inhibit two key cytokines=
driving inflammatory processes =E2=80=93 interleukin 17A (IL-17A) and inte=
rleukin 17F (IL-17F).1 The approval of bimekizumab is supported by data fro=
m three Phase 3, multicenter, randomized, placebo and/or active comparator-=
controlled trials (BE READY, BE VIVID and BE SURE), which evaluated the eff=
icacy and safety of bimekizumab in 1,480 adults with moderate to severe pla=
que psoriasis.^2,3,4=C2=A0 =C2=A0=C2=A0
=E2=80=9CToday=E2=80=99s FDA approval for BIMZELX is an exciting milestone =
that reflects our commitment to continuously improving the standard of care=
in plaque psoriasis and to raising expectations of what treatment can deli=
ver. We know that completely clear skin is valued by people with psoriasis =
and, in our Phase 3 trials, at week 16, 85-91% of patients treated with bim=
ekizumab achieved clear or almost clear skin, with 59-68% achieving the goa=
l of complete clearance,=E2=80=9D said Emmanuel Caeymaex, Executive Vice Pr=
esident, Immunology Solutions and Head of U.S., UCB. =E2=80=9CWith bimekizu=
mab now approved for psoriasis, we will move forward rapidly to submit appl=
ications for additional indications in the U.S.=E2=80=9D=C2=A0
=E2=80=9CWe have been eagerly awaiting bimekizumab, the first IL-17A and IL=
-17F inhibitor, to be approved in the U.S. for the treatment of adults with=
moderate to severe plaque psoriasis. In Phase 3/3b trials, bimekizumab ach=
ieved superior levels of skin clearance at week 16 compared to placebo and =
three existing biologics for psoriasis, with responses being rapid and last=
ing up to a year. Long-term data have also shown that the majority of patie=
nts maintained high levels of clinical response through three years,=E2=80=
=9D said Mark Lebwohl, MD, bimekizumab investigator, Dean for Clinical Ther=
apeutics, Icahn School of Medicine at Mount Sinai, and Chairman Emeritus, K=
imberly and Eric J. Waldman Department of Dermatology.
Psoriasis affects more than 7.5 million adults in the U.S. and impacts much=
more than the skin itself.^5 In addition to the recognized skin symptoms s=
uch as itching and flaking, psoriasis can place strains on patients and the=
ir families, impacting work, relationships and home lives.^6,7=C2=A0 A U.S.=
observational study (n=3D846) reported that only one in four patients achi=
eved self-assessed complete skin clearance after six months of treatment wi=
th biologics highlighting the burden of plaque psoriasis and the need for a=
dditional new treatment options.^8=C2=A0 =C2=A0=C2=A0
The FDA recommended dosage of bimekizumab for psoriasis patients is 320 mg =
(given as two subcutaneous injections of 160 mg each) at Weeks 0, 4, 8, 12 =
and 16, then every 8 weeks thereafter.^1 For patients weighing =E2=89=A5120=
kg, a dose of 320 mg every 4 weeks after week 16 may be considered.^1 Bime=
kizumab may be administered by a healthcare professional, or a patient may =
self-inject after proper training.^1 Bimekizumab is available as an autoinj=
ector and a pre-filled syringe.^1 Bimekizumab will be available in the U.S.=
in approximately one month.
=E2=80=9CThe approval of bimekizumab will provide an important new treatmen=
t option for adults living with moderate to severe plaque psoriasis,=E2=80=
=9D said Leah McCormick Howard, J.D., President and CEO for the National Ps=
oriasis Foundation. =E2=80=9COur hope is that new treatments translate into=
improved outcomes for many and help alleviate the physical and emotional b=
urden of psoriasis.=E2=80=9D
Jean-Christophe Tellier, CEO, UCB added, =E2=80=9CWe are pleased to deliver=
new options for people living with severe diseases as part of an unprecede=
nted series of product launches from UCB around the world. Delivering these=
solutions draws on our scientific expertise and understanding of disease b=
iology and our legacy of deep understanding of patients to provide differen=
tiated treatments. Our continued work embodies what UCB stands for =E2=80=
=93 that we are inspired by patients, driven by science.=E2=80=9D
UCB expects global peak sales for BIMZELX of at least =E2=82=AC4bn.
Key Findings from the Phase 3 Clinical Development Program=C2=A0
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).^2,3,4 All studies met their co-primary endp=
oints and all ranked secondary endpoints.^2,3,4
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).^2,3,4 Ranked secondary =
endpoints included PASI 75 at week 4 and PASI 100 (complete skin clearance)=
at week 16.^2,3,4 Key findings across all studies include:
=C2=B7 Clear or Almost Clear Skin: More than eight out of 10 patients recei=
ving bimekizumab (320 mg every four weeks [Q4W]) achieved PASI 90 and IGA 0=
/1 at week 16.^2,3,4 =C2=A0
=C2=B7 Complete Skin Clearance: Approximately six out of 10 patients receiv=
ing bimekizumab (320 mg Q4W) achieved PASI 100 at week 16.^2,3,4
=C2=B7 Speed of Response: Clinical responses achieved with bimekizumab were=
rapid, with more than seven out of 10 patients achieving PASI 75 at week 4=
following one dose (320 mg).^2,3,4
=C2=B7 Maintenance of Response: Clinical responses achieved with bimekizuma=
b at week 16 (PASI 90 and PASI 100) were maintained for up to one year.^2,3=
,4 Long-term data showed that clinical responses were maintained in the vas=
t majority of patients through to three years of bimekizumab treatment.^9=
=C2=A0
The most common adverse reactions (=E2=89=A5 1%) are upper respiratory infe=
ctions, oral candidiasis, headache, injection site reactions, tinea infecti=
ons, gastroenteritis, Herpes Simplex Infections, acne, folliculitis, other =
Candida infections, and fatigue.^1
Notes to Editors: =C2=A0
Dr. Lebwohl is an investigator for UCB. He has not accepted any consulting =
payments from UCB.
About BIMZELX (bimekizumab-bkzx)
Bimekizumab is a humanized IgG1 monoclonal antibody that selectively binds =
to IL-17A, IL-17F and IL-17AF cytokines, blocking their interaction with th=
e IL-17RA/IL-17RC receptor complex.1 Elevated levels =C2=A0of IL-17A and IL=
-17F are found in lesional psoriatic skin.^1=C2=A0
Please see Important Safety Information below and full U.S. prescribing inf=
ormation at www.UCB-USA.com/Innovation/Products/BIMZELX (http://www.ucb-usa=
.com/Innovation/Products/BIMZELX) =C2=A0and www.BIMZELX.com (http://www.bim=
zelx.com/) .
BIMZELX U.S. IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY INFORMATION
Suicidal Ideation and Behavior
BIMZELX^=C2=AE (bimekizumab-bkzx) may increase the risk of suicidal ideatio=
n and behavior (SI/B). =C2=A0A causal association between treatment with BI=
MZELX and increased risk of SI/B has not been established. =C2=A0Prescriber=
s should weigh the potential risks and benefits before using BIMZELX in pat=
ients with a history of severe depression or SI/B. Advise monitoring for th=
e emergence or worsening of depression, suicidal ideation, or other mood ch=
anges. If such changes occur, advise to promptly seek medical attention, re=
fer to a mental health professional as appropriate, and re-evaluate the ris=
ks and benefits of continuing treatment.=C2=A0
Infections
BIMZELX may increase the risk of infections. Do not initiate treatment with=
BIMZELX in patients with any clinically important active infection until t=
he infection resolves or is adequately treated. =C2=A0In patients with a ch=
ronic infection or a history of recurrent infection, consider the risks and=
benefits prior to prescribing BIMZELX. =C2=A0Instruct patients to seek med=
ical advice if signs or symptoms suggestive of clinically important infecti=
on occur. If a patient develops such an infection or is not responding to s=
tandard therapy, monitor the patient closely and do not administer BIMZELX =
until the infection resolves.
Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treat=
ment with BIMZELX. Avoid the use of BIMZELX in patients with active TB infe=
ction. Initiate treatment of latent TB prior to administering BIMZELX. Cons=
ider anti-TB therapy prior to initiation of BIMZELX in patients with a past=
history of latent or active TB in whom an adequate course of treatment can=
not be confirmed. Closely monitor patients for signs and symptoms of active=
TB during and after treatment.
Liver Biochemical Abnormalities
Elevated serum transaminases were reported in clinical trials with BIMZELX.=
Test liver enzymes, alkaline phosphatase and bilirubin at baseline, period=
ically during treatment with BIMZELX and according to routine patient manag=
ement. =C2=A0If treatment-related increases in liver enzymes occur and drug=
-induced liver injury is suspected, interrupt BIMZELX until a diagnosis of =
liver injury is excluded. =C2=A0Permanently discontinue use of BIMZELX in p=
atients with causally associated combined elevations of transaminases and b=
ilirubin. =C2=A0Avoid use of BIMZELX in patients with acute liver disease o=
r cirrhosis.
Inflammatory Bowel Disease
Cases of inflammatory bowel disease (IBD) have been reported in patients tr=
eated with IL-17 inhibitors, including BIMZELX. =C2=A0Avoid use of BIMZELX =
in patients with active IBD. =C2=A0During BIMZELX treatment, monitor patien=
ts for signs and symptoms of IBD and discontinue treatment if new onset or =
worsening of signs and symptoms occurs.
Immunizations
Prior to initiating therapy with BIMZELX, complete all age-appropriate vacc=
inations according to current immunization guidelines. Avoid the use of liv=
e vaccines in patients treated with BIMZELX. =C2=A0
Most Common Adverse Reactions
Most common adverse reactions (=E2=89=A5 1%) are upper respiratory infectio=
ns, oral candidiasis, headache, injection site reactions, tinea infections,=
gastroenteritis, Herpes Simplex Infections, acne, folliculitis, other Cand=
ida infections, and fatigue.
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%, 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 i=
n patients with any clinically important active infection. Patients treated=
with bimekizumab should be instructed to seek medical advice if signs or s=
ymptoms suggestive of an infection occur. If a patient develops an infectio=
n the patient should be carefully monitored. If the infection becomes serio=
us or is not responding to standard therapy, treatment should be discontinu=
ed until the infection resolves. Prior to initiating treatment with bimekiz=
umab, patients should be evaluated for tuberculosis (TB) infection. Bimekiz=
umab should not be given in patients with active TB. Patients receiving bim=
ekizumab 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 =C2=A0
*EU/EEA means European Union/European Economic Area =C2=A0 =C2=A0 =C2=A0 =
=C2=A0
Last accessed: October 2023.
=E2=96=BCThis medicinal product is subject to additional monitoring. This w=
ill allow quick identification of new safety information. Healthcare profes=
sionals 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
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=
=E2=80=9D, =E2=80=9Cplans=E2=80=9D, =E2=80=9Cseeks=E2=80=9D, =E2=80=9Cestim=
ates=E2=80=9D, =E2=80=9Cmay=E2=80=9D, =E2=80=9Cwill=E2=80=9D, =E2=80=9Ccont=
inue=E2=80=9D and similar expressions. These forward-looking statements are=
based on current plans, estimates and beliefs of management. All statement=
s, other than statements of historical facts, are statements that could be =
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ng margins, capital expenditures, cash, other financial information, expect=
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ing statements are not guarantees of future performance and are subject to =
known and unknown risks, uncertainties and assumptions which might cause th=
e actual results, financial condition, performance or achievements of UCB, =
or industry results, to differ materially from those that may be expressed =
or implied by such forward-looking statements contained in this press relea=
se. Important factors that could result in such differences include: change=
s in general economic, business and competitive conditions, the inability t=
o obtain necessary regulatory approvals or to obtain them on acceptable ter=
ms or within expected timing, costs associated with research and developmen=
t, changes in the prospects for products in the pipeline or under developme=
nt by UCB, effects of future judicial decisions or governmental investigati=
ons, safety, quality, data integrity or manufacturing issues; potential or =
actual data security and data privacy breaches, or disruptions of our infor=
mation technology systems, product liability claims, challenges to patent p=
rotection for products or product candidates, competition from other produc=
ts including biosimilars, changes in laws or regulations, exchange rate flu=
ctuations, changes or uncertainties in tax laws or the administration of su=
ch laws, and hiring and retention of its employees. There is no guarantee t=
hat new product candidates will be discovered or identified in the pipeline=
, will progress to product approval or that new indications for existing pr=
oducts will be developed and approved. Movement from concept to commercial =
product is uncertain; preclinical results do not guarantee safety and effic=
acy of product candidates in humans. So far, the complexity of the human bo=
dy cannot be reproduced in computer models, cell culture systems or animal =
models. The length of the timing to complete clinical trials and to get reg=
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ts similar unpredictability going forward. Products or potential products, =
which are the subject of partnerships, joint ventures or licensing collabor=
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rove to be not as safe, effective or commercially successful as UCB may hav=
e believed at the start of such partnership. UCB=E2=80=99s efforts to acqui=
re other products or companies and to integrate the operations of such acqu=
ired companies may not be as successful as UCB may have believed at the mom=
ent of acquisition. Also, UCB or others could discover safety, side effects=
or manufacturing problems with its products and/or devices after they are =
marketed. The discovery of significant problems with a product similar to o=
ne of UCB=E2=80=99s products that implicate an entire class of products may=
have a material adverse effect on sales of the entire class of affected pr=
oducts. Moreover, sales may be impacted by international and domestic trend=
s toward managed care and health care cost containment, including pricing p=
ressure, political and public scrutiny, customer and prescriber patterns or=
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activities and outcomes. Finally, a breakdown, cyberattack or information s=
ecurity breach could compromise the confidentiality, integrity and availabi=
lity of UCB=E2=80=99s data and systems.=C2=A0
Given these uncertainties, you should not place undue reliance on any of su=
ch forward-looking statements. There can be no guarantee that the investiga=
tional or approved products described in this press release will be submitt=
ed or approved for sale or for any additional indications or labelling in a=
ny market, or at any particular time, nor can there be any guarantee that s=
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future.
UCB is providing this information, including forward-looking statements, on=
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required pursuant to applicable laws and regulations.=C2=A0
Additionally, information contained in this document shall not constitute a=
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References
1. BIMZELX (bimekizumab) U.S. Prescribing Information https://www.ucb-usa.c=
om/Innovation/Products/BIMZELX. Last accessed: October 2023.
2. 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=E2=80=93498.
3. 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=E2=80=93486.
4. Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus Adalimumab in =
Plaque Psoriasis. N Engl J Med. 2021;385(2):130=E2=80=93141.
5. National Psoriasis Foundation. About Psoriasis webpage. Available at: ht=
tps://www.psoriasis.org/about-psoriasis (https://www.psoriasis.org/about-ps=
oriasis/) /Last accessed: October 2023.
6. Armstrong AW, Schupp C, Wu J, et al. Quality of life and work productivi=
ty impairment among psoriasis patients: findings from the National Psoriasi=
s Foundation survey data 2003-2011. PLoS One. 2012;7:e52935.=C2=A0
7. Eghlileb AM, Davies EEG, Finlay AY. Psoriasis has a major secondary impa=
ct on the lives of family members and partners. Br J Dermatol. 2007;156(6):=
1245=E2=80=931250.
8. Seneschal J, Lacour J-P ,Bewley A et al. A multinational, prospective, o=
bservational study to estimate complete skin clearance in patients with mod=
erate-to-severe plaque PSOriasis treated with BIOlogics in a REAL world set=
ting (PSO-BIO-REAL). J Eur Acad Dermatol Venereol. 2020 Nov;34(11):2566-257=
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9. Strober B, Tada Y, Mrowietz U et al. Bimekizumab maintenance of response=
through three years in patients with moderate to severe plaque psoriasis w=
ho responded at Week 16: Results from the BE BRIGHT open-label extension tr=
ial. Br J Dermatol. 2023; 24;188(6):749-759.
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