UCB (EBR:UCB) UCB Media Room: UCB Submits Response to FDA Complete Response Letter for Bimekizumab
Directive transparence : information réglementée
22/11/2022 18:31
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** UCB Submits Response to FDA Complete Response Letter for Bimekizumab
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Brussels (Belgium), 22nd November 2022 =E2=80=93 18:30 (CET) =E2=80=93 UCB,=
a global biopharmaceutical company, today announced that it has resubmitte=
d the Biologics License Application (BLA) to the U.S. Food and Drug Adminis=
tration (FDA) for bimekizumab for the treatment of adults with moderate to =
severe plaque psoriasis.
The resubmission follows the receipt of a Complete Response Letter (CRL) fr=
om the FDA in May 2022 (https://www.ucb.com/stories-media/Press-Releases/ar=
ticle/Update-on-US-FDA-Review-of-Biologics-License-Application-BLA-for-bime=
kizumab-0) which stated that certain pre-license inspection observations mu=
st be resolved before the application may be approved. The CRL was not due =
to efficacy or safety.
The FDA is expected to determine whether the resubmission constitutes a com=
plete response, and if so, the classification of the resubmission will be c=
ommunicated.^1=C2=A0
=C2=A0=C2=A0 =C2=A0
Notes to editors:
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.^2
In the U.S., the efficacy and safety of bimekizumab have not been establish=
ed for any indication and it is not approved by the FDA.
In August 2021, bimekizumab was approved in the European Union (EU)/Europea=
n Economic Area (EEA) and in Great Britain, for the treatment of moderate t=
o severe plaque psoriasis in adults who are candidates for systemic therapy=
.^3,4=C2=A0 In January 2022, bimekizumab received marketing authorization i=
n Japan for the treatment of plaque psoriasis, generalized pustular psorias=
is and psoriatic erythroderma in patients who are not sufficiently respondi=
ng to existing treatments.^5 In February, March and July 2022, bimekizumab =
received marketing authorization in Canada and Australia respectively, for =
the treatment of moderate to severe plaque psoriasis in adults who are cand=
idates for systemic therapy or phototherapy.^6,7=C2=A0In July and October 2=
022, bimekizumab received marketing authorization in Saudi Arabia and Switz=
erland respectively, for the treatment of moderate to severe plaque psorias=
is in adults who are candidates for systemic therapy.^8,9
BIMZELX^=C2=AE=C2=A0=E2=96=BC=C2=A0(bimekizumab) EU/EEA Important Safety In=
formation in Psoriasis^3
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 and fatigue. Elder=
ly may be more likely to experience certain adverse reactions such 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: May 2022.
Last accessed: November 2022.
=E2=96=BC=C2=A0=C2=A0 =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 reacti=
ons.=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 8,600 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.
Forward looking statements=C2=A0
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ns. So far, the complexity of the human body cannot be reproduced in comput=
er models, cell culture systems or animal models. The length of the timing =
to complete clinical trials and to get regulatory approval for product mark=
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forward. Products or potential products, which are the subject of partners=
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or commercially successful as UCB may have believed at the start of such p=
artnership. UCB=E2=80=99s efforts to acquire other products or companies an=
d to integrate the operations of such acquired companies may not be as succ=
essful as UCB may have believed at the moment of acquisition. Also, UCB or =
others could discover safety, side effects or manufacturing problems with i=
ts products and/or devices after they are marketed. The discovery of signif=
icant problems with a product similar to one of UCB=E2=80=99s products that=
implicate an entire class of products may have a material adverse effect o=
n sales of the entire class of affected products. Moreover, sales may be im=
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care cost containment, including pricing pressure, political and public scr=
utiny, customer and prescriber patterns or practices, and the reimbursement=
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opharmaceutical pricing and reimbursement activities and outcomes. Finally,=
a breakdown, cyberattack or information security breach could compromise t=
he confidentiality, integrity and availability of UCB=E2=80=99s data and sy=
stems.=C2=A0
Given these uncertainties, you should not place undue reliance on any of su=
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future.
UCB is providing this information, including forward-looking statements, on=
ly as of the date of this press release and it does not reflect any potenti=
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UCB is following the worldwide developments diligently to assess the financ=
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References
1. FDA - Classifying Resubmissions of Original NDAs, BLAs, and Efficacy Sup=
plements in Response to Complete Response Letters https://www.fda.gov/files=
/about%20fda/published/Classifying-Resubmissions-of-Original-NDAs--BLAs--an=
d-Efficacy-Supplements-in-Response-to-Action-Letters.pdf (https://www.fda.g=
ov/files/about fda/published/Classifying-Resubmissions-of-Original-NDAs--BL=
As--and-Efficacy-Supplements-in-Response-to-Action-Letters.pdf) Last Access=
ed: November 2022
2. Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bi=
mekizumab, 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.
3. BIMZELX^=C2=AE (bimekizumab) EU Summary of Product Characteristics, May =
2022. https://www.ema.europa.eu/en/documents/product-information/bimzelx-ep=
ar-product-information_en.pdf. Last Accessed: November 2022
4. BIMZELX^=C2=AE (bimekizumab) GB Summary of Product Characteristics. Avai=
lable at: https://www.medicines.org.uk/emc/product/12834/smpc#gref. Last Ac=
cessed: November 2022
5. Pharmaceuticals and Medical Devices Agency https://www.pmda.go.jp/englis=
h/ Last Accessed: November 2022
6. BIMZELX (bimekizumab) Canada Product Monograph. Available at: https://pd=
f.hres.ca/dpd_pm/00064702.PDF =C2=A0Last Accessed: November 2022 =C2=A0=C2=
=A0
7. Therapeutics Drug Administration https://www.tga.gov.au/resources/auspmd=
/bimzelx Last Accessed: November 2022
8. Saudi Food & Drug Authority https://www.sfda.gov.sa/en (http://www.sfda.=
gov.sa/en) Last Accessed: November 2022
9. Swissmedic Available at https://www.swissmedic.ch/swissmedic/de/home/hum=
anarzneimittel/authorisations/new-medicines/bimzelx-injlsg-fertigspritze-bi=
mekizumabum.html Last Accessed: November 2022=C2=A0
GenericFile
UCB PR bimekizumab Nov 22 2022 ENG (https://mb.cision.com/Public/18595/3670=
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