{"id":497183,"date":"2024-01-26T13:47:06","date_gmt":"2024-01-26T18:47:06","guid":{"rendered":"https:\/\/platohealth.ai\/eosinophilic-esophagitis-medicine-approval-expanded\/"},"modified":"2024-01-26T20:05:58","modified_gmt":"2024-01-27T01:05:58","slug":"eosinophilic-esophagitis-medicine-approval-expanded","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/eosinophilic-esophagitis-medicine-approval-expanded\/","title":{"rendered":"Eosinophilic esophagitis medicine approval expanded","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"
Approval of the first treatment for patients one year old and over with eosinophilic esophagitis (EoE) was based on trial data showing a greater proportion of children given Dupixent achieved histological remission compared to placebo.<\/p>\n<\/div>\n
The US Food and Drug Administration (FDA) has approved<\/a> Dupixent \u00ae<\/sup> (dupilumab) as a treatment for children patients aged one to 11 years, weighing at least 15kg with eosinophilic esophagitis (EoE).<\/p>\n This new authorisation by the FDA\u2019s expands its initial approval for EoE in May 2022 for patients aged 12 years and older, weighing at least 40kg.<\/p>\n \u201cWith this approval, Dupixent becomes the first and only treatment option for EoE patients aged one year and older, weighing at least 15kg\u201d<\/p>\n<\/div>\n \u201cWith this approval, Dupixent becomes the first and only treatment option for EoE patients aged one year and older, weighing at least 15kg. By targeting the underlying type 2 inflammation that contributes to this disease, Dupixent has the potential to transform the standard of care for these children as it has for adults and adolescents with EoE,\u201d Dr George Yancopoulos, PhD, Board co-chair, President and Chief Scientific Officer at Regeneron<\/a> shared.<\/p>\n Sanofi and Regeneron Pharmaceuticals highlighted that as a non-immunosuppressant, the fully human monoclonal antibody inhibits signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways.<\/p>\n First medicine approved in EU for eosinophilic esophagitis<\/a><\/p>\n<\/blockquote>\n This FDA approval of the biologic treatment is based on data from the two-part Phase III EoE KIDS trial (Part A and Part B) evaluating the efficacy and safety of Dupixent in children aged one to 11 years with EoE.<\/p>\n According to Regeneron Pharmaceuticals and Sanofi:<\/p>\n Dr Yancopoulos explained that the disease is \u201cdebilitating and progressive\u201d and threatens a patient\u2019s basic ability to eat.<\/p>\n \u201c\u2026 despite existing treatment options, 40 percent of [children with eosinophilic esophagitis] in the US under the age of 12 continue to experience symptoms of this disease,\u201d stated Dr Naimish Patel, Head of Global Development, Immunology and Inflammation at Sanofi.<\/p>\n Big Pharma<\/a>, Biologics<\/a>, Biopharmaceuticals<\/a>, Clinical Development<\/a>, Clinical Trials<\/a>, Drug Markets<\/a>, Drug Safety<\/a>, Industry Insight<\/a>, Regulation & Legislation<\/a>, Research & Development (R&D)<\/a>, Therapeutics<\/a><\/p>\n<\/div>\n<\/div>\n Approval of the first treatment for patients one year old and over with eosinophilic esophagitis (EoE) was based on trial data showing a greater proportion of children given Dupixent achieved histological remission compared to placebo. The US Food and Drug Administration (FDA) has approved Dupixent \u00ae (dupilumab) as a treatment for children patients aged one […]<\/p>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"author":2,"featured_media":497187,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[49],"tags":[],"acf":[],"gt_translate_keys":[{"key":"link","format":"url"}],"_links":{"self":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/497183"}],"collection":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/comments?post=497183"}],"version-history":[{"count":1,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/497183\/revisions"}],"predecessor-version":[{"id":497186,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/497183\/revisions\/497186"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media\/497187"}],"wp:attachment":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media?parent=497183"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/categories?post=497183"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/tags?post=497183"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Dupixent<\/h2>\n
A promising biologic<\/h3>\n
\n
What did the data from the Phase III Dupixent study show?<\/h2>\n
\n
Eosinophilic esophagitis \u2013 addressing an unmet need<\/h2>\n
Related topics<\/h3>\n
\n