{"id":2947,"date":"2026-07-02T08:12:21","date_gmt":"2026-07-02T08:12:21","guid":{"rendered":"https:\/\/whmnews.ir\/En\/?p=2947"},"modified":"2026-07-02T08:12:21","modified_gmt":"2026-07-02T08:12:21","slug":"us-fda-approves-vertexs-gene-therapy-for-sickle-cell-disease-in-children-as-young-as-two","status":"publish","type":"post","link":"https:\/\/whmnews.ir\/En\/index.php\/2026\/07\/02\/us-fda-approves-vertexs-gene-therapy-for-sickle-cell-disease-in-children-as-young-as-two\/","title":{"rendered":"US FDA approves Vertex&#8217;s gene therapy for sickle cell disease in children as young as two"},"content":{"rendered":"<p><strong>US FDA approves Vertex&#8217;s gene therapy for sickle cell disease in children as young as two<\/strong><\/p>\n<p>The U.S. Food and Drug Administration approved expanded use of Vertex Pharmaceuticals&#8217;\u00a0<a href=\"https:\/\/www.reuters.com\/markets\/companies\/VRTX.O\">(VRTX.O), opens new tab<\/a>\u00a0gene therapy in children as \u200byoung as two with inherited blood disorders, including \u200csickle cell disease, the first such treatment cleared for this age group.<\/p>\n<p>Casgevy, a one-time treatment made from a patient&#8217;s own blood stem \u200bcells, was previously approved for patients aged 12 \u200band older with sickle cell disease or transfusion-dependent \u2060beta thalassemia.<\/p>\n<ul>\n<li>Sickle cell disease is a \u200bpainful, inherited blood disorder in which the body makes sickle-shaped \u200bhemoglobin, preventing red blood cells from properly carrying oxygen to the body&#8217;s tissues.<\/li>\n<li>In a trial of children aged five to under 12 \u200bwith sickle cell disease, all eight evaluable patients had \u200bno severe vaso-occlusive crises or painful episodes for at least 12 straight \u200cmonths \u2060within the first 24 months of infusion.<\/li>\n<li>In beta thalassemia, eight of nine evaluable children achieved transfusion independence for 12 consecutive months, with a median duration of 20.1 months.<\/li>\n<li>The \u200bFDA granted approval \u200bto Vertex \u2060in 53 days after filing under the Commissioner&#8217;s National Priority Voucher, its new fast-track \u200bprogram designed to shorten review time for a \u200bdrug \u2060application.<\/li>\n<li>In 2023, the FDA\u00a0<a href=\"https:\/\/www.reuters.com\/business\/healthcare-pharmaceuticals\/us-approves-two-gene-therapies-sickle-cell-disease-2023-12-08\/\">approved<\/a>\u00a0Vertex&#8217;s and Genetix Biotherapeutics&#8217; gene therapies for sickle cell disease in patients 12 years and older.<\/li>\n<li>Other \u2060long-term \u200btreatment options for sickle cell disease \u200binclude bone marrow transplant, which requires matching donors, and the chemotherapy drug \u200bhydroxyurea.<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>US FDA approves Vertex&#8217;s gene therapy for sickle cell disease in children as young as two The U.S. Food and Drug Administration approved expanded use of Vertex Pharmaceuticals&#8217;\u00a0(VRTX.O), opens new tab\u00a0gene therapy in children as \u200byoung as two with inherited blood disorders, including \u200csickle cell disease, the first such treatment cleared for this age group. [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":2948,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[12],"tags":[973],"class_list":["post-2947","post","type-post","status-publish","format-standard","has-post-thumbnail","category-food-and-drug-organization","tag-us-fda-approves-vertexs-gene-therapy-for-sickle-cell-disease-in-children-as-young-as-two"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v24.1 (Yoast SEO v24.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>US FDA approves Vertex&#039;s gene therapy for sickle cell disease in children as young as two - whmnews<\/title>\n<meta name=\"description\" content=\"US FDA approves Vertex&#039;s gene therapy for sickle cell disease in children as young as two\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link 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