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
https://mb.cision.com/Public/18595/3670611/b35d1142fa4a1983_800x800ar.png ** UCB Submits Response to FDA Complete Response Letter for Bimekizumab ------------------------------------------------------------ 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 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. 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= 611/858b020cd36248ca.pdf) ______________________ If you would rather not receive future communications from UCB SA, please g= o to https://eu.vocuspr.com/OptOut.aspx?2973226x20421x122478x1x6868579x2400= 0x6&Email=3Dregnews%40symexglobal.com. UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . B - 1070 Belgium