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** Update on U.S. FDA Review of Biologics License Application (BLA) for bim=
ekizumab
------------------------------------------------------------
=C2=B7 The U.S. FDA has informed UCB via letter that the Agency were unable=
to complete review of the BLA for bimekizumab by the PDUFA date and is def=
erring action on the application
=C2=B7 The Agency cited only the inability to conduct on-site facility insp=
ections due to travel restrictions as the reason for deferral
=C2=B7 UCB is committed to bringing bimekizumab to patients with moderate t=
o severe plaque psoriasis in the U.S. as soon as possible and continues to =
work with the FDA to support the ongoing review
=C2=A0
Brussels, Belgium =E2=80=93 16th, October, 2021 =E2=80=93 16:00 CEST =E2=80=
=93 Regulated Information =E2=80=93 Inside Information =E2=80=93 UCB, a glo=
bal biopharmaceutical company, today announced that the U.S. Food and Drug =
Administration (FDA) has informed the Company that they were unable to comp=
lete review of the Biologics License Application (BLA) for bimekizumab for =
the treatment of moderate to severe plaque psoriasis by the Prescription Dr=
ug User Fee Action (PDUFA) date of October 15, 2021. =C2=A0
The Agency has determined that on-site inspections of the European manufact=
uring facilities for bimekizumab are required before the FDA can approve th=
e application. The FDA indicated that they were unable to conduct the inspe=
ctions during the current review cycle due to COVID-19 related restrictions=
on travel. Therefore, the FDA is deferring action on the application until=
the inspections can be completed. In the letter, the Agency cited only tra=
vel restrictions and its inability to complete facility inspections as the =
reason for the deferral. The BLA for bimekizumab remains under review.
Under FDA guidance relating to pre-approval inspections during the COVID-19=
pandemic, the Agency may defer action on a pending application when a faci=
lity inspection is planned but cannot be completed by the PDUFA goal date d=
ue to COVID-related travel restrictions, provided that no deficiencies have=
been identified and the application otherwise satisfies the requirements f=
or approval.^1
=E2=80=9CWe are currently in contact with the FDA to schedule the inspectio=
ns of our manufacturing facilities as soon as possible,=E2=80=9D said Prof.=
Dr. Iris Loew Friedrich, Chief Medical Officer and Executive Vice Presiden=
t, Development UCB. =E2=80=9CWe have provided the Agency with the manufactu=
ring schedules through the first quarter of 2022, and we are eager to assis=
t the FDA to allow its assessment of bimekizumab to be finalized. We are co=
mmitted to bringing bimekizumab to patients in the U.S. with moderate to se=
vere plaque psoriasis as soon as possible.=E2=80=9D=C2=A0
In August 2021, bimekizumab received marketing authorization in countries o=
f the European Union (EU)/European Economic Area (EEA) and Great Britain, f=
or the treatment of moderate to severe plaque psoriasis in adults who are c=
andidates for systemic therapy.^2,3=C2=A0 Bimekizumab is not approved by an=
y other regulatory authority outside the EU/EEA and Great Britain. Regulato=
ry reviews are underway in Australia, Canada, Switzerland and Japan.
UCB=E2=80=99s financial guidance for 2021 and 2025 remains unchanged.
About Psoriasis=C2=A0
Psoriasis is a common, chronic inflammatory disease with primary involvemen=
t of the skin.^4=C2=A0This skin condition affects men and women of all ages=
and ethnicities.^4 Psoriasis signs and symptoms can vary but may include r=
ed patches of skin covered with silvery scales; dry, cracked skin that may =
bleed; and thickened, pitted or ridged nails.^5=C2=A0Psoriasis also has a c=
onsiderable psychological and quality-of-life impact, potentially affecting=
work, recreation, relationships, sexual functioning, family and social lif=
e.^6
Unmet needs remain in the treatment of psoriasis. A population-based survey=
identified that approximately one in three psoriasis patients reported tha=
t their primary goals of therapy, including keeping symptoms under control,=
reducing itching and decreasing flaking, were not met with their current t=
reatment.^7=C2=A0
About bimekizumab
Bimekizumab is an investigational humanized monoclonal IgG1 antibody that s=
electively and directly inhibits both interleukin 17A (IL-17A) and interleu=
kin 17F (IL-17F), two key cytokines driving inflammatory processes.^8=C2=A0=
Selective inhibition of IL-17F in addition to IL-17A has been shown to supp=
ress inflammation to a greater extent than IL-17A inhibition alone.^8,9=C2=
=A0=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=C2=A0
of the immune system or of the central nervous system. With approximately 8=
,400 people in nearly 40 countries, the company generated revenue of =E2=82=
=AC5.3 billion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). F=
ollow us on Twitter: @UCB_news.
=C2=A0=C2=A0 =C2=A0
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=
=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
For further information, contact UCB:=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
Corporate Communications
Laurent Schots=C2=A0
Media Relations, UCB =C2=A0
T+32.2.559.92.64 =C2=A0Laurent.schots@ucb.com=C2=A0
Immunology Communications US
Nicole Herga
Immunology Communications U.S.
T +1.404.226.7591 nicole.herga@ucb.com=C2=A0
=C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0=C2=A0
References
1. U.S. Food and Drug Administration. Manufacturing, Supply Chain, and Drug=
Inspections - COVID-19. Available at: https://www.fda.gov/drugs/coronaviru=
s-covid-19-drugs/manufacturing-supply-chain-and-drug-inspections-covid-19 L=
ast accessed: October 2021.=C2=A0
2. 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: October 2021.
3. BIMZELX (bimekizumab) GB Summary of Product Characteristics https://www.=
medicines.org.uk/emc/product/12834; https://www.medicines.org.uk/emc/produc=
t/12833 Last accessed: October 2021.
4. National Psoriasis Foundation. About Psoriasis. Available at: https://ww=
w.psoriasis.org/about-psoriasis (https://www.psoriasis.org/about-psoriasis/=
/) /. Last accessed: October 2021.
5. International Federation of Psoriasis Associations. Available at: www.if=
pa-pso.com/our-cause// (http://www.ifpa-pso.com/our-cause//) . Last accesse=
d: October 2021.
6. Moon HS, Mizara A, McBride SR. Psoriasis and psycho-dermatology. Dermato=
l Ther (Heidelb). 2013;3(2):117-130.
7. Lebwohl MG, Kavanaugh A, Armstrong AW, et al. US Perspectives in the Man=
agement of Psoriasis and Psoriatic Arthritis: Patient and=C2=A0Physician Re=
sults from the Population-Based Multinational Assessment of Psoriasis and P=
soriatic Arthritis (MAPP) Survey. Am J Clin=C2=A0Dermatol. 2016;17(1):87-97=
.
8. Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bi=
mekizumab, a humanized monoclonal antibody and selective dual=C2=A0inhibito=
r of IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):=
991-1001.
9. Glatt S, Baeten D, Baker T, et al. Dual IL-17A and IL-17F neutralisation=
by bimekizumab in psoriatic arthritis: evidence from preclinical=C2=A0expe=
riments and a randomised placebo-controlled clinical trial that IL-17F cont=
ributes to human chronic tissue inflammation. Ann Rheum=C2=A0Dis. 2018;77(4=
):523-532.
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