{"id":59685,"date":"2024-09-20T12:04:39","date_gmt":"2024-09-20T12:04:39","guid":{"rendered":"https:\/\/english.saigonbiz.com.vn\/2024\/09\/20\/press-release-dupixent-recommended-for-eu-approval-by-the-chmp-to-treat-eosinophilic-esophagitis-in-children-as-young-as-1-year-old\/"},"modified":"2024-09-20T12:04:39","modified_gmt":"2024-09-20T12:04:39","slug":"press-release-dupixent-recommended-for-eu-approval-by-the-chmp-to-treat-eosinophilic-esophagitis-in-children-as-young-as-1-year-old","status":"publish","type":"post","link":"https:\/\/english.saigonbiz.com\/vn\/press-release-dupixent-recommended-for-eu-approval-by-the-chmp-to-treat-eosinophilic-esophagitis-in-children-as-young-as-1-year-old\/","title":{"rendered":"Press Release: Dupixent recommended for EU approval by the CHMP to treat eosinophilic esophagitis in children as young as 1 year old"},"content":{"rendered":"<div>\n<p align=\"left\"><em>Dupixent recommended for EU approval by the CHMP to treat eosinophilic esophagitis in children as young as 1 year old <\/em><\/p>\n<ul type=\"disc\">\n<li style=\"text-align:justify;\">Recommendation based on a phase 3 study showing a significantly greater proportion of children on Dupixent achieved histological remission, compared to placebo, consistent with improvements seen in adults and adolescents<\/li>\n<li style=\"text-align:justify;\">If approved, Dupixent would be the first and only medicine in the EU indicated for EoE in this age group<\/li>\n<\/ul>\n<p align=\"justify\"><strong>Paris and Tarrytown, NY, September 20, 2024. <\/strong>The European Medicines Agency\u2019s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the expanded approval of Dupixent (dupilumab) in the European Union (EU) for eosinophilic esophagitis (EoE) in children down to 1 year of age. The recommendation is for children aged 1 to 11 years who weigh at least 15 kg and who are inadequately controlled by, intolerant to, or who are not candidates for conventional medicinal therapy. The European Commission is expected to announce a final decision in the coming months. Dupixent is already <a href=\"https:\/\/www.sanofi.com\/en\/media-room\/press-releases\/2023\/2023-01-30-06-00-00-2597236\" rel=\"nofollow noopener\" target=\"_blank\" title=\"approved\">approved<\/a> in the EU for certain adults and adolescents aged 12 years and older with EoE.<\/p>\n<p align=\"justify\">The positive CHMP opinion is supported by a two-part (Part A and B) EoE KIDS phase 3 study in children aged one to 11 years. In Part A, a significantly greater proportion of children receiving weight-based doses of Dupixent achieved histological disease remission at week 16, compared to placebo, with results sustained for up to one year in Part B. At week 16, caregivers of children treated with Dupixent also observed improvements in the frequency and severity of EoE signs, and fewer days with at least one sign of EoE, compared to placebo. These data established a bridge showing the response to Dupixent in children with EoE is similar to that of the approved adult and adolescent EoE populations. <\/p>\n<p align=\"justify\">The safety results in the EoE KIDS study were generally consistent with the known safety profile of Dupixent in adolescents and adults with EoE. AEs more commonly observed with Dupixent (\u226510%) in either weight-based dosing regimen compared to placebo during Part A were COVID-19, nausea, injection site pain and headache. The long-term safety profile of Dupixent evaluated in Part B was similar to that observed during Part A. <\/p>\n<p align=\"justify\">Results from the study were recently <a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2312282\" rel=\"nofollow noopener\" target=\"_blank\" title=\"published\">published<\/a> in <em>The New England Journal of Medicine<\/em>.<\/p>\n<p align=\"justify\">The use of Dupixent in children aged one to 11 years with EoE is investigational in the EU and is not yet approved. <\/p>\n<p align=\"justify\"><strong>About EoE<\/strong><br \/>EoE is a chronic, progressive disease associated with type-2 inflammation that is thought to be responsible for damaging the esophagus and impairing its function. Diagnosis is difficult, as symptoms can be mistaken for other conditions and there are delays in diagnosis. EoE can severely impact a child\u2019s ability to eat and may also cause vomiting, abdominal pain, difficulty swallowing, decreased appetite and challenges thriving. Continuous management of EoE may be needed to reduce the risk of complications and disease progression.<\/p>\n<p align=\"justify\"><strong>About Dupixent<\/strong><br \/>Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL4) and interleukin-13 (IL13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type-2 inflammation in phase 3 studies, establishing that IL4 and IL13 are key and central drivers of the type-2 inflammation that plays a major role in multiple related and often co-morbid diseases.<\/p>\n<p align=\"justify\">Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, EoE, prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease in different age populations. More than 1,000,000 patients are being treated with Dupixent globally.<\/p>\n<p align=\"left\"><strong>Dupilumab development program<\/strong><br \/>Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical studies involving more than 10,000 patients with various chronic diseases driven in part by type-2 inflammation.<\/p>\n<p align=\"justify\">In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type-2 inflammation or other allergic processes in phase 3 studies, including chronic pruritus of unknown origin and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority.<\/p>\n<p align=\"justify\"><strong>About Regeneron <\/strong><br \/>Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and\u00a0product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. <\/p>\n<p align=\"justify\">Regeneron\u00a0pushes the boundaries of scientific discovery and\u00a0accelerates drug development\u00a0using\u00a0our proprietary technologies, such as\u00a0<em>VelociSuite<\/em><sup><em>\u00ae<\/em><\/sup><em>,<\/em> which produces optimized fully human antibodies and new classes of bispecific antibodies.\u00a0We are shaping the next frontier of medicine with data-powered insights from the\u00a0Regeneron Genetics Center<sup>\u00ae<\/sup>\u00a0and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.<\/p>\n<p align=\"justify\">For more information, please visit <a href=\"https:\/\/www.regeneron.com\/\" rel=\"nofollow noopener\" target=\"_blank\" title=\"www.Regeneron.com\">www.Regeneron.com<\/a> or follow Regeneron on <a href=\"https:\/\/www.linkedin.com\/company\/regeneron-pharmaceuticals\/\" rel=\"nofollow noopener\" target=\"_blank\" title=\"LinkedIn\">LinkedIn<\/a><u>, <\/u><a href=\"https:\/\/www.instagram.com\/regeneron\" rel=\"nofollow noopener\" target=\"_blank\" title=\"Instagram\">Instagram<\/a>,\u00a0<a href=\"https:\/\/www.facebook.com\/Regeneron\/\" rel=\"nofollow noopener\" target=\"_blank\" title=\"Facebook\u00a0\">Facebook\u00a0<\/a>or\u00a0<a href=\"https:\/\/twitter.com\/Regeneron\" rel=\"nofollow noopener\" target=\"_blank\" title=\"X\">X<\/a>.<\/p>\n<p align=\"left\"><em>About Sanofi<\/em><br \/>We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people\u2019s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. <\/p>\n<p align=\"justify\">Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY<\/p>\n<p align=\"left\"><em>Sanofi Media Relations<\/em><br \/><strong>Sandrine Guendoul <\/strong>| + 33 6 25 09 14 25 | <a href=\"mailto:sandrine.guendoul@sanofi.com\" rel=\"nofollow noopener\" target=\"_blank\" title=\"sandrine.guendoul@sanofi.com\">sandrine.guendoul@sanofi.com<\/a><br \/><strong>Evan Berland\u00a0<\/strong>|\u00a0+ 1 215 432 0234 |<u>\u00a0<\/u><a href=\"mailto:evan.berland@sanofi.com\" rel=\"nofollow noopener\" target=\"_blank\" title=\"evan.berland@sanofi.com\">evan.berland@sanofi.com<\/a><br \/><strong>Victor Rouault<\/strong> | + 33 6 70 93 71 40 | <a href=\"mailto:victor.rouault@sanofi.com\" rel=\"nofollow noopener\" target=\"_blank\" title=\"victor.rouault@sanofi.com\">victor.rouault@sanofi.com<\/a><br \/><strong>Timothy Gilbert\u00a0<\/strong>|\u00a0+ 1 516 521 2929 | <a href=\"http:\/\/invalid.uri\/\" rel=\"nofollow noopener\" target=\"_blank\" title=\"timothy.gilbert@sanofi.com\">timothy.gilbert@sanofi.com<\/a><\/p>\n<p align=\"left\"><em>Sanofi Investor Relations<\/em><br \/><strong>Thomas Kudsk Larsen<\/strong> |+ 44 7545 513 693 | <a href=\"mailto:thomas.larsen@sanofi.com\" rel=\"nofollow noopener\" target=\"_blank\" title=\"thomas.larsen@sanofi.com\">thomas.larsen@sanofi.com<\/a><br \/><strong>Aliz\u00e9 Kaisserian\u00a0<\/strong>|\u00a0+ 33 6 47 04 12 11 | <a href=\"mailto:alize.kaisserian@sanofi.com\" rel=\"nofollow noopener\" target=\"_blank\" title=\"alize.kaisserian@sanofi.com\">alize.kaisserian@sanofi.com<\/a><br \/><strong>Arnaud Del\u00e9pine\u00a0<\/strong>|\u00a0+ 33 6 73 69 36 93 |<a href=\"mailto:arnaud.delepine@sanofi.com\" rel=\"nofollow noopener\" target=\"_blank\" title=\"arnaud.delepine@sanofi.com\">arnaud.delepine@sanofi.com<\/a><br \/><strong>Felix Lauscher\u00a0<\/strong>|\u00a0+ 1\u00a0908\u00a0612 7239 | <a href=\"mailto:felix.lauscher@sanofi.com\" rel=\"nofollow noopener\" target=\"_blank\" title=\"felix.lauscher@sanofi.com\">felix.lauscher@sanofi.com<\/a><br \/><strong>Keita Browne\u00a0<\/strong>|\u00a0+ 1 781 249 1766 | <a href=\"mailto:keita.browne@sanofi.com\" rel=\"nofollow noopener\" target=\"_blank\" title=\"keita.browne@sanofi.com\">keita.browne@sanofi.com<\/a><br \/><strong>Nathalie Pham\u00a0<\/strong>|\u00a0+ 33 7 85 93 30 17 | <a href=\"mailto:nathalie.pham@sanofi.com\" rel=\"nofollow noopener\" target=\"_blank\" title=\"nathalie.pham@sanofi.com\">nathalie.pham@sanofi.com<\/a><br \/><strong>Tarik Elgoutni <\/strong>| + 1 617 710 3587 | <a href=\"mailto:tarik.elgoutni@sanofi.com\" rel=\"nofollow noopener\" target=\"_blank\" title=\"tarik.elgoutni@sanofi.com\">tarik.elgoutni@sanofi.com<\/a><br \/><strong>Thibaud Ch\u00e2telet<\/strong> | + 33 6 80 80 89 90 | <a href=\"mailto:thibaud.chatelet@sanofi.com\" rel=\"nofollow noopener\" target=\"_blank\" title=\"thibaud.chatelet@sanofi.com\">thibaud.chatelet@sanofi.com<\/a><\/p>\n<p align=\"left\"><em>Regeneron Media Relations<\/em><br \/><strong>Hannah Kwagh\u00a0<\/strong>| +1 914-847-6314 |\u00a0<a href=\"mailto:hannah.kwagh@regeneron.com\" rel=\"nofollow noopener\" target=\"_blank\" title=\"hannah.kwagh@regeneron.com\">hannah.kwagh@regeneron.com<\/a><\/p>\n<p align=\"left\"><em>Regeneron Investor Relations<\/em><br \/><strong>Vesna Tosic\u00a0<\/strong>| + 914-847-5443 |\u00a0<a href=\"mailto:vesna.tosic@regeneron.com\" rel=\"nofollow noopener\" target=\"_blank\" title=\"vesna.tosic@regeneron.com\">vesna.tosic@regeneron.com<\/a><\/p>\n<p align=\"left\"><strong>Sanofi forward-looking statements<\/strong><br \/><em>This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words \u201cexpects\u201d, \u201canticipates\u201d, \u201cbelieves\u201d, \u201cintends\u201d, \u201cestimates\u201d, \u201cplans\u201d and similar expressions. Although Sanofi\u2019s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under \u201cRisk Factors\u201d and \u201cCautionary Statement Regarding Forward-Looking Statements\u201d in Sanofi\u2019s annual report on Form 20-F for the year ended December 31, 2023. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.<\/em><\/p>\n<p align=\"justify\"><em>All trademarks mentioned in this press release are the property of the Sanofi group with the exception of VelociSuite and Regeneron Genetics Center.<\/em><\/p>\n<p align=\"left\"><strong>Regeneron Forward-Looking Statements<\/strong><br \/><em>This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (\u201cRegeneron\u201d or the \u201cCompany\u201d), and actual events or results may differ materially from these forward-looking statements. Words such as \u201canticipate,\u201d \u201cexpect,\u201d \u201cintend,\u201d \u201cplan,\u201d \u201cbelieve,\u201d \u201cseek,\u201d \u201cestimate,\u201d variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and\/or its collaborators or licensees (collectively, \u201cRegeneron\u2019s Products\u201d) and product candidates being developed by Regeneron and\/or its collaborators or licensees (collectively, \u201cRegeneron\u2019s Product Candidates\u201d) and research and clinical programs now underway or planned, including without limitation Dupixent\u00ae (dupilumab); the impact of the opinion adopted by the European Medicines Agency&#8217;s Committee for Medicinal Products for Human Use discussed in this press release on the potential approval by the European Commission of Dupixent to treat eosinophilic esophagitis (\u201cEoE\u201d) in children aged 1 to 11 years; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron\u2019s Product Candidates and new indications for Regeneron\u2019s Products, such as Dupixent for the treatment of pediatric EoE in the European Union as discussed in this press release as well as for the treatment of chronic pruritus of unknown origin, bullous pemphigoid, and other potential indications; uncertainty of the utilization, market acceptance, and commercial success of Regeneron\u2019s Products and Regeneron\u2019s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing; the ability of Regeneron\u2019s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron\u2019s Products and Regeneron\u2019s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regeneron\u2019s Products (such as Dupixent) and Regeneron\u2019s Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron\u2019s Products and Regeneron\u2019s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron\u2019s ability to continue to develop or commercialize Regeneron\u2019s Products and Regeneron\u2019s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron\u2019s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron\u2019s Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron\u2019s Products and Regeneron\u2019s Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and\/or its collaborators or licensees may be replicated in other studies and\/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron\u2019s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on Regeneron&#8217;s business; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA\u00ae (aflibercept) Injection), other litigation and other proceedings and government investigations relating to the Company and\/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney&#8217;s Office for the District of Massachusetts), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron\u2019s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron\u2019s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2023 and its Form 10-Q for the quarterly period ended June 30, 2024. Any forward-looking statements are made based on management\u2019s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. <\/em><\/p>\n<p align=\"justify\"><em>Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron&#8217;s media and investor relations website (https:\/\/investor.regeneron.com) and its LinkedIn page (https:\/\/www.linkedin.com\/company\/regeneron-pharmaceuticals).<\/em><\/p>\n<p>\u00a0<\/p>\n<p id=\"gnw_attachments_section-header\">\n    <strong>Attachment<\/strong>\n<\/p>\n<ul id=\"gnw_attachments_section-items\">\n<li>\n        <a target=\"_blank\" href=\"https:\/\/ml-eu.globenewswire.com\/Resource\/Download\/b2c419be-484f-4e2a-9be9-80f2c8d309b9\" title=\"Press Release\" rel=\"nofollow noopener\">Press Release<\/a>\n      <\/li>\n<\/ul>\n<p><img decoding=\"async\" src=\"https:\/\/ml-eu.globenewswire.com\/media\/MzE0ZjcxNWYtODAyOC00MTI5LWEyMjEtMjg3OTJmNTcyODU4LTEwMTExMTA=\/tiny\/Sanofi-Aventis-Groupe.png\" referrerpolicy=\"no-referrer-when-downgrade\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Dupixent recommended for EU approval by the CHMP to treat eosinophilic esophagitis in children as young as 1 year old Recommendation based on a phase 3 study showing a significantly greater proportion of children on Dupixent achieved histological remission, compared to placebo, consistent with improvements seen in adults and adolescents If approved, Dupixent would be [&#8230;]\n","protected":false},"author":1,"featured_media":59686,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-59685","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pr-newswire"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.6 (Yoast SEO v21.6) - 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