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** UCB Announces FDA Acceptance of BLA Resubmission for Bimekizumab
------------------------------------------------------------
=C2=B7 The FDA designated the BLA resubmission as =E2=80=98Class 2=E2=80=99=
with a six-month review period
=C2=B7 The FDA action is expected in Q2 2023=C2=A0
Brussels (Belgium), 23 December 2022 =E2=80=93 07:00 (CET) =E2=80=93 UCB, a=
global biopharmaceutical company, today announced that the U.S. Food and D=
rug Administration (FDA) has accepted for review the Biologics License Appl=
ication (BLA) resubmission for bimekizumab for the treatment of adults with=
moderate to severe plaque psoriasis. The FDA designated the resubmission a=
s =E2=80=98Class 2=E2=80=99 with a six-month review period. The FDA action =
is expected in the second quarter of 2023.=C2=A0
=E2=80=9CThe FDA acceptance of our resubmitted application for bimekizumab =
is positive news that moves us one step closer to providing the first dual =
IL-17A and IL-17F inhibitor to address the unmet needs of people with moder=
ate to severe plaque psoriasis in the U.S. We will continue to work with th=
e FDA through the review process with the goal of bringing bimekizumab to t=
he dermatology community in the U.S. as soon as possible,=E2=80=9D said Emm=
anuel Caeymaex, Executive Vice President, Immunology Solutions and Head of =
U.S., UCB.
In November 2022 (https://www.ucb.com/stories-media/Press-Releases/article/=
UCB-Submits-Response-to-FDA-Complete-Response-Letter-for-Bimekizumab) , UCB=
announced resubmission of the BLA for bimekizumab, for the treatment of ad=
ults with moderate to severe plaque psoriasis, following receipt of a compl=
ete response letter in May 2022.=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.^1
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 U.S. Food and Drug Admi=
nistration (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=
.^2,3 In January 2022, bimekizumab received marketing authorization in Japa=
n for the treatment of plaque psoriasis, generalized pustular psoriasis and=
psoriatic erythroderma in patients who are not sufficiently responding to =
existing treatments.^4
In February and March 2022, bimekizumab received marketing authorization in=
Canada and Australia respectively, for the treatment of moderate to severe=
plaque psoriasis in adults who are candidates for systemic therapy or phot=
otherapy.^5,6=C2=A0 In July and October 2022, bimekizumab received marketin=
g authorization in Saudi Arabia and Switzerland respectively, for the treat=
ment of moderate to severe plaque psoriasis in adults who are candidates fo=
r systemic therapy.^7,8
BIMZELX^=C2=AE=C2=A0=E2=96=BC (bimekizumab) EU/EEA Important Safety Informa=
tion in Psoriasis^2
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: December 2022.
Last accessed: December 2022.
=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
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
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 =
deemed forward-looking statements, including estimates of revenues, operati=
ng margins, capital expenditures, cash, other financial information, expect=
ed legal, arbitration, political, regulatory or clinical results or practic=
es and other such estimates and results. By their nature, such forward-look=
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: the gl=
obal spread and impact of COVID-19, changes in general economic, business a=
nd competitive conditions, the inability to obtain necessary regulatory app=
rovals or to obtain them on acceptable terms or within expected timing, cos=
ts associated with research and development, changes in the prospects for p=
roducts in the pipeline or under development by UCB, effects of future judi=
cial decisions or governmental investigations, safety, quality, data integr=
ity or manufacturing issues; potential or actual data security and data pri=
vacy breaches, or disruptions of our information technology systems, produc=
t liability claims, challenges to patent protection for products or product=
candidates, competition from other products including biosimilars, changes=
in laws or regulations, exchange rate fluctuations, changes or uncertainti=
es in tax laws or the administration of such laws, and hiring and retention=
of its employees. There is no guarantee that new product candidates will b=
e discovered or identified in the pipeline, will progress to product approv=
al or that new indications for existing products will be developed and appr=
oved. Movement from concept to commercial product is uncertain; preclinical=
results do not guarantee safety and efficacy of product candidates in huma=
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=
eting has varied in the past and UCB expects similar unpredictability going=
forward. Products or potential products, which are the subject of partners=
hips, joint ventures or licensing collaborations may be subject to differen=
ces disputes between the partners or may prove to be not as safe, effective=
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=
pacted by international and domestic trends toward managed care and health =
care cost containment, including pricing pressure, political and public scr=
utiny, customer and prescriber patterns or practices, and the reimbursement=
policies imposed by third-party payers as well as legislation affecting bi=
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=
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=
uch products will be or will continue to be commercially successful in the =
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=
al impact from the evolving COVID-19 pandemic, unless indicated otherwise. =
UCB is following the worldwide developments diligently to assess the financ=
ial significance of this pandemic to UCB. UCB expressly disclaims any duty =
to update any information contained in this press release, either to confir=
m the actual results or to report or reflect any change in its forward-look=
ing statements with regard thereto or any change in events, conditions or c=
ircumstances on which any such statement is based, unless such statement is=
required pursuant to applicable laws and regulations.=C2=A0
Additionally, information contained in this document shall not constitute a=
n offer to sell or the solicitation of an offer to buy any securities, nor =
shall there be any offer, solicitation or sale of securities in any jurisdi=
ction in which such offer, solicitation or sale would be unlawful prior to =
the registration or qualification under the securities laws of such jurisdi=
ction.=C2=A0
References
1. 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. =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0=C2=
=A0
2. BIMZELX^=C2=AE (bimekizumab) EU Summary of Product Characteristics, Dece=
mber 2022. Available at: https://www.ema.europa.eu/en/documents/product-inf=
ormation/bimzelx-epar-product-information_en.pdf. Last Accessed: December 2=
022.
3. BIMZELX^=C2=AE (bimekizumab) GB Summary of Product Characteristics. Avai=
lable at: https://www.medicines.org.uk/emc/product/12834/smpc#gref Last Acc=
essed: December 2022.
4. Pharmaceuticals and Medical Devices Agency. New Drugs Approved in FY 202=
1. https://www.pmda.go.jp/files/000246734.pdf. Last Accessed: December 2022=
.
5. BIMZELX^=C2=AE (bimekizumab) Canada Product Monograph. Available at: htt=
ps://pdf.hres.ca/dpd_pm/00064702.PDF =C2=A0Last Accessed: December 2022. =
=C2=A0=C2=A0
6. Therapeutics Drug Administration Available at: https://www.tga.gov.au/re=
sources/auspmd/bimzelx Last Accessed: December 2022
7. Saudi Food & Drug Authority https://www.sfda.gov.sa/en (http://www.sfda.=
gov.sa/en) Last Accessed: December 2022.
8. Swissmedic Available at: https://www.swissmedic.ch/swissmedic/de/home/hu=
manarzneimittel/authorisations/new-medicines/bimzelx-injlsg-fertigspritze-b=
imekizumabum.html Last Accessed: December 2022.
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