{"id":3477,"date":"2025-04-01T17:31:55","date_gmt":"2025-04-01T14:31:55","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=3477"},"modified":"2025-04-04T10:01:49","modified_gmt":"2025-04-04T07:01:49","slug":"three-ongoing-clinical-trials-of-elevidys-gene-therapy-temporarily-halted-in-europe","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/ar\/three-ongoing-clinical-trials-of-elevidys-gene-therapy-temporarily-halted-in-europe\/","title":{"rendered":"\u062b\u0644\u0627\u062b \u062a\u062c\u0627\u0631\u0628 \u0633\u0631\u064a\u0631\u064a\u0629 \u062c\u0627\u0631\u064a\u0629 \u0644\u0639\u0644\u0627\u062c \u0627\u0644\u062c\u064a\u0646 Elevidys \u062a\u0648\u0642\u0641\u062a \u0645\u0624\u0642\u062a\u064b\u0627 \u0641\u064a \u0623\u0648\u0631\u0648\u0628\u0627"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u0623\u0648\u0642\u0641\u062a \u0627\u0644\u0648\u0643\u0627\u0644\u0629 \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u0629 \u0644\u0644\u0623\u062f\u0648\u064a\u0629 (EMA) \u0645\u0624\u0642\u062a\u064b\u0627 \u062b\u0644\u0627\u062b \u062a\u062c\u0627\u0631\u0628 \u0633\u0631\u064a\u0631\u064a\u0629 \u062c\u0627\u0631\u064a\u0629 \u0644\u062f\u0648\u0627\u0621 \u0625\u064a\u0644\u064a\u0641\u064a\u062f\u064a\u0633 (\u062f\u064a\u0644\u0627\u0646\u062f\u0633\u062a\u0631\u0648\u062c\u064a\u0646 \u0645\u0648\u0643\u0633\u064a\u0628\u0627\u0631\u0641\u0648\u0641\u064a\u0643-\u0631\u0648\u0643\u0644)\u060c \u0648\u0647\u0648 \u0639\u0644\u0627\u062c \u062c\u064a\u0646\u064a \u0637\u0648\u0631\u062a\u0647 \u0634\u0631\u0643\u0629 \u0633\u0627\u0631\u064a\u0628\u062a\u0627 \u0648\u0633\u0648\u0651\u0642\u062a\u0647 \u0634\u0631\u0643\u0629 \u0631\u0648\u0634. \u0648\u0642\u062f \u0623\u062b\u0627\u0631 \u0647\u0630\u0627 \u0627\u0644\u062e\u0628\u0631\u060c \u0648\u0625\u0646 \u0643\u0627\u0646 \u0645\u062a\u0648\u0642\u0639\u064b\u0627\u060c \u062d\u0632\u0646\u064b\u0627 \u0639\u0645\u064a\u0642\u064b\u0627 \u0644\u062f\u0649 \u0645\u0631\u0636\u0649 \u0636\u0645\u0648\u0631 \u0627\u0644\u0639\u0636\u0644\u0627\u062a \u062f\u0648\u0634\u064a\u0646 (DMD).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0648\u062a\u0634\u0645\u0644 \u0627\u0644\u062a\u062c\u0627\u0631\u0628 \u0627\u0644\u0645\u062a\u0648\u0642\u0641\u0629 \u062f\u0631\u0627\u0633\u0629 Envision \u0627\u0644\u062a\u064a \u062a\u0631\u0639\u0627\u0647\u0627 \u0634\u0631\u0643\u0629 Sarepta \u0641\u064a \u0627\u0644\u0645\u0631\u062d\u0644\u0629 \u0627\u0644\u062b\u0627\u0644\u062b\u0629\u060c \u0648\u0627\u0644\u062a\u064a \u062a\u0642\u064a\u0645 Elevidys \u0644\u062f\u0649 \u0627\u0644\u0623\u0648\u0644\u0627\u062f \u0627\u0644\u0630\u064a\u0646 \u062a\u062a\u0631\u0627\u0648\u062d \u0623\u0639\u0645\u0627\u0631\u0647\u0645 \u0628\u064a\u0646 8 \u0625\u0644\u0649 17 \u0639\u0627\u0645\u064b\u0627\u061b \u0648\u062f\u0631\u0627\u0633\u0629 Envol \u0627\u0644\u062a\u064a \u062a\u0631\u0639\u0627\u0647\u0627 \u0634\u0631\u0643\u0629 Roche \u0641\u064a \u0627\u0644\u0645\u0631\u062d\u0644\u0629 \u0627\u0644\u062b\u0627\u0646\u064a\u0629\u060c \u0648\u0627\u0644\u062a\u064a \u062a\u0628\u062d\u062b \u0641\u064a Elevidys \u0644\u062f\u0649 \u0627\u0644\u0623\u0637\u0641\u0627\u0644 \u0648\u0627\u0644\u0645\u0648\u0627\u0644\u064a\u062f \u0627\u0644\u062c\u062f\u062f\u061b \u0648\u062f\u0631\u0627\u0633\u0629 Sarepta&#039;s Study 104\u060c \u0648\u0647\u064a \u0646\u0638\u0631\u0629 \u0641\u064a \u0627\u0644\u0645\u0631\u062d\u0644\u0629 \u0627\u0644\u0623\u0648\u0644\u0649 \u0639\u0644\u0649 Elevidys \u0644\u062f\u0649 \u0627\u0644\u0623\u0648\u0644\u0627\u062f \u0627\u0644\u0630\u064a\u0646 \u062a\u062a\u0631\u0627\u0648\u062d \u0623\u0639\u0645\u0627\u0631\u0647\u0645 \u0628\u064a\u0646 4 \u0625\u0644\u0649 9 \u0633\u0646\u0648\u0627\u062a \u0645\u0639 \u0648\u062c\u0648\u062f \u0623\u062c\u0633\u0627\u0645 \u0645\u0636\u0627\u062f\u0629 \u0645\u0633\u0628\u0642\u0629 \u0644\u0646\u0645\u0637 \u0645\u0635\u0644 \u0645\u0639\u064a\u0646.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0642\u0628\u0644 \u0631\u0648\u0634 \u0648\u0633\u0627\u0631\u064a\u0628\u062a\u0627 \u0648EMA\u060c \u0643\u0627\u0646 \u0623\u0648\u0644 \u0645\u062c\u062a\u0645\u0639 \u064a\u0646\u0634\u0631 \u0647\u0630\u0627 \u0627\u0644\u0625\u0639\u0644\u0627\u0646 \u0647\u0648 \u0634\u0631\u064a\u0643\u0646\u0627 \u0627\u0644\u062a\u0631\u0643\u064a &gt;&gt;&gt; <a href=\"https:\/\/dmd.arti.net\/\" target=\"_blank\" rel=\"noreferrer noopener\">DMD Dayanisma<\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0648\u0642\u062f \u0623\u0635\u062f\u0631\u062a \u0634\u0631\u0643\u0629 \u0631\u0648\u0634 \u0631\u0633\u0627\u0644\u0629 \u0625\u0644\u0649 \u0627\u0644\u0645\u062c\u062a\u0645\u0639 \u0648\u0627\u0644\u062a\u064a \u064a\u0645\u0643\u0646\u0643 \u0642\u0631\u0627\u0621\u062a\u0647\u0627 \u0647\u0646\u0627. (<a href=\"https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/04\/March-2025-Roche-DMD-Temporary-Clinical-Study-Halt-Community-Letter_31Mar25.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">\u0645\u0644\u0641 \u0628\u064a \u062f\u064a \u0625\u0641<\/a>)<\/p>\n\n\n\n<div class=\"wp-block-rank-math-toc-block\" id=\"rank-math-toc\"><h2>\u062c\u062f\u0648\u0644 \u0627\u0644\u0645\u062d\u062a\u0648\u064a\u0627\u062a<\/h2><nav><ul><li><a href=\"#why-were-elevidys-clinical-trials-halted\">\u0644\u0645\u0627\u0630\u0627 \u062a\u0645 \u0625\u064a\u0642\u0627\u0641 \u0627\u0644\u062a\u062c\u0627\u0631\u0628 \u0627\u0644\u0633\u0631\u064a\u0631\u064a\u0629 \u0644\u0640 Elevidys\u061f<\/a><ul><li><a href=\"#srp-9001-104\">SRP-9001-104 \u0645\u062a\u0648\u0642\u0641 \u0645\u0624\u0642\u062a\u064b\u0627<\/a><\/li><li><a href=\"#envol-study-302\">ENVOL (\u062f\u0631\u0627\u0633\u0629 302) \u0645\u062a\u0648\u0642\u0641 \u0645\u0624\u0642\u062a\u064b\u0627<\/a><\/li><li><a href=\"#srp-9001-303\">SRP-9001-303 \u0645\u062a\u0648\u0642\u0641 \u0645\u0624\u0642\u062a\u064b\u0627<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"why-were-elevidys-clinical-trials-halted\">\u0644\u0645\u0627\u0630\u0627 \u062a\u0645 \u0625\u064a\u0642\u0627\u0641 \u0627\u0644\u062a\u062c\u0627\u0631\u0628 \u0627\u0644\u0633\u0631\u064a\u0631\u064a\u0629 \u0644\u0640 Elevidys\u061f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u0628\u0639\u062f \u0648\u0641\u0627\u0629 \u0635\u0628\u064a \u064a\u0628\u0644\u063a \u0645\u0646 \u0627\u0644\u0639\u0645\u0631 16 \u0639\u0627\u0645\u064b\u0627 \u0645\u0635\u0627\u0628\u064b\u0627 \u0628\u0636\u0645\u0648\u0631 \u0627\u0644\u0639\u0636\u0644\u0627\u062a \u062f\u0648\u0634\u064a\u0646 \u0648\u0627\u0644\u0630\u064a \u062a\u0644\u0642\u0649 \u062c\u0631\u0639\u0629 \u0645\u0646 Elevidys \u0641\u064a 18 \u0645\u0627\u0631\u0633 2025\u060c \u062a\u063a\u064a\u0631\u062a \u062a\u0648\u0642\u0639\u0627\u062a \u0627\u0644\u0639\u0644\u0627\u062c \u0627\u0644\u062c\u064a\u0646\u064a\u060c \u0627\u0644\u0630\u064a \u064a\u062a\u0645 \u062a\u0633\u0648\u064a\u0642\u0647 \u0628\u0633\u0639\u0631 \u062a\u062c\u0627\u0631\u064a \u0642\u062f\u0631\u0647 $3 \u0645\u0644\u064a\u0648\u0646 \u062f\u0648\u0644\u0627\u0631\u060c \u0628\u0634\u0643\u0644 \u0645\u0641\u0627\u062c\u0626.<a href=\"https:\/\/dmdwarrior.com\/ar\/sixteen-year-old-dies-after-receiving-sareptas-duchenne-gene-therapy-elevidys\/\">\u0627\u0642\u0631\u0623 \u0627\u0644\u0645\u0632\u064a\u062f<\/a>)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0625\u0644\u0649 \u062d\u064a\u0646 \u062a\u062d\u062f\u064a\u062f \u0627\u0644\u0633\u0628\u0628 \u0627\u0644\u062f\u0642\u064a\u0642 \u0644\u0648\u0641\u0627\u0629 \u0645\u0631\u0627\u0647\u0642 \u0623\u0645\u0631\u064a\u0643\u064a \u0623\u0635\u064a\u0628 \u0628\u0641\u0634\u0644 \u0643\u0628\u062f\u064a \u062d\u0627\u062f (ALF) \u0628\u0639\u062f \u062a\u0646\u0627\u0648\u0644\u0647 \u062f\u0648\u0627\u0621 Elevidys\u060c \u0637\u0644\u0628\u062a \u0648\u0643\u0627\u0644\u0629 \u0627\u0644\u0623\u062f\u0648\u064a\u0629 \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u0629 (EMA) \u062a\u0639\u0644\u064a\u0642 \u0627\u0644\u062f\u0631\u0627\u0633\u0627\u062a. \u0648\u0639\u0646\u062f\u0645\u0627 \u062a\u0648\u0641\u064a \u0627\u0644\u0645\u0631\u064a\u0636 \u0627\u0644\u0634\u0647\u0631 \u0627\u0644\u0645\u0627\u0636\u064a\u060c \u0623\u0639\u0644\u0646\u062a \u0634\u0631\u0643\u0629 \u0633\u0627\u0631\u064a\u0628\u062a\u0627 \u0623\u0646\u0647\u0627 \u0633\u062a\u064f\u0639\u062f\u0651\u0644 \u0645\u0644\u0635\u0642 \u062f\u0648\u0627\u0621 Elevidys \u0644\u064a\u0634\u0645\u0644 \u0625\u0634\u0627\u0631\u0629 \u0627\u0644\u0633\u0644\u0627\u0645\u0629.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"srp-9001-104\">SRP-9001-104 \u0645\u062a\u0648\u0642\u0641 \u0645\u0624\u0642\u062a\u064b\u0627<\/h3>\n\n\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"762\" height=\"113\" src=\"https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/04\/SRP-9001-104-HALTED.jpg\" alt=\"\u062a\u0648\u0642\u0641\u062a \u0645\u0624\u0642\u062a\u064b\u0627 \u0627\u0644\u062a\u062c\u0631\u0628\u0629 \u0627\u0644\u0633\u0631\u064a\u0631\u064a\u0629 SRP-9001-104 \u0644\u0644\u0639\u0644\u0627\u062c \u0627\u0644\u062c\u064a\u0646\u064a Elevidys \u0641\u064a \u0623\u0648\u0631\u0648\u0628\u0627\" class=\"wp-image-3480\" title=\"\" srcset=\"https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/04\/SRP-9001-104-HALTED.jpg 762w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/04\/SRP-9001-104-HALTED-300x44.jpg 300w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/04\/SRP-9001-104-HALTED-18x3.jpg 18w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/04\/SRP-9001-104-HALTED-150x22.jpg 150w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/04\/SRP-9001-104-HALTED-696x103.jpg 696w\" sizes=\"auto, (max-width: 762px) 100vw, 762px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u0645\u0635\u062f\u0631: <a href=\"https:\/\/euclinicaltrials.eu\/ctis-public\/view\/2024-512624-11-00?lang=en\" target=\"_blank\" rel=\"noopener\">\u0627\u0644\u062a\u062c\u0631\u0628\u0629 \u0627\u0644\u0633\u0631\u064a\u0631\u064a\u0629 \u0644\u0640 SRP-9001-104<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"envol-study-302\">ENVOL (\u062f\u0631\u0627\u0633\u0629 302) \u0645\u062a\u0648\u0642\u0641 \u0645\u0624\u0642\u062a\u064b\u0627<\/h3>\n\n\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"762\" height=\"272\" src=\"https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/04\/ENVOL-Study-302-Halted.jpg\" alt=\"\u062a\u0648\u0642\u0641\u062a \u0645\u0624\u0642\u062a\u064b\u0627 \u0641\u064a \u0623\u0648\u0631\u0648\u0628\u0627 \u0627\u0644\u062a\u062c\u0631\u0628\u0629 \u0627\u0644\u0633\u0631\u064a\u0631\u064a\u0629 ENVOL (\u062f\u0631\u0627\u0633\u0629 302) \u0644\u0644\u0639\u0644\u0627\u062c \u0627\u0644\u062c\u064a\u0646\u064a Elevidys\" class=\"wp-image-3481\" title=\"\" srcset=\"https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/04\/ENVOL-Study-302-Halted.jpg 762w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/04\/ENVOL-Study-302-Halted-300x107.jpg 300w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/04\/ENVOL-Study-302-Halted-18x6.jpg 18w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/04\/ENVOL-Study-302-Halted-150x54.jpg 150w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/04\/ENVOL-Study-302-Halted-696x248.jpg 696w\" sizes=\"auto, (max-width: 762px) 100vw, 762px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u0645\u0635\u062f\u0631: <a href=\"https:\/\/euclinicaltrials.eu\/ctis-public\/view\/2023-509901-57-00?lang=en\" target=\"_blank\" rel=\"noopener\">\u0627\u0644\u062a\u062c\u0631\u0628\u0629 \u0627\u0644\u0633\u0631\u064a\u0631\u064a\u0629 \u0644\u0640 SRP-9001-302<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"srp-9001-303\">SRP-9001-303 \u0645\u062a\u0648\u0642\u0641 \u0645\u0624\u0642\u062a\u064b\u0627<\/h3>\n\n\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"768\" height=\"313\" src=\"https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/04\/SRP-9001-303-Halted.jpg\" alt=\"\u062a\u0648\u0642\u0641\u062a \u0645\u0624\u0642\u062a\u064b\u0627 \u0627\u0644\u062a\u062c\u0631\u0628\u0629 \u0627\u0644\u0633\u0631\u064a\u0631\u064a\u0629 SRP-9001-303 \u0644\u0644\u0639\u0644\u0627\u062c \u0627\u0644\u062c\u064a\u0646\u064a Elevidys \u0641\u064a \u0623\u0648\u0631\u0648\u0628\u0627\" class=\"wp-image-3482\" title=\"\" srcset=\"https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/04\/SRP-9001-303-Halted.jpg 768w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/04\/SRP-9001-303-Halted-300x122.jpg 300w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/04\/SRP-9001-303-Halted-18x7.jpg 18w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/04\/SRP-9001-303-Halted-150x61.jpg 150w, https:\/\/dmdwarrior.com\/wp-content\/uploads\/2025\/04\/SRP-9001-303-Halted-696x284.jpg 696w\" sizes=\"auto, (max-width: 768px) 100vw, 768px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u0645\u0635\u062f\u0631: <a href=\"https:\/\/euclinicaltrials.eu\/ctis-public\/view\/2024-512626-28-00?lang=en\" target=\"_blank\" rel=\"noopener\">\u0627\u0644\u062a\u062c\u0631\u0628\u0629 \u0627\u0644\u0633\u0631\u064a\u0631\u064a\u0629 \u0644\u0640 SRP-9001-303<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u064a\u062a\u0639\u0644\u0645 \u0623\u0643\u062b\u0631: <a href=\"https:\/\/dmdwarrior.com\/ar\/dmd-warriors-turkish-representative-shares-his-views-on-elevidys-gene-therapy-is-it-effective-and-why-is-it-expensive\/\">\u0645\u0645\u062b\u0644 DMD WarrioR \u0627\u0644\u062a\u0631\u0643\u064a \u064a\u0634\u0627\u0631\u0643 \u0622\u0631\u0627\u0621\u0647 \u062d\u0648\u0644 \u0627\u0644\u0639\u0644\u0627\u062c \u0627\u0644\u062c\u064a\u0646\u064a Elevidys.<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>Three ongoing clinical trials of ELEVIDYS (delandistrogene moxeparvovec-rokl), a gene therapy developed by Sarepta and marketed by Roche, have been temporarily halted by the European Medicines Agency (EMA). This expected but not unwelcome news has caused deep sadness in the Duchenne muscular dystrophy (DMD) community. The paused trials include the Sarepta-sponsored phase 3 Envision study, [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":3478,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[242,33,179,91,84,213,61,203,65],"class_list":["post-3477","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-clinical-trials","tag-elevidys","tag-elevidys-gene-therapy","tag-ema","tag-europe","tag-european-medicines-agency","tag-gene-therapy","tag-roche","tag-sarepta"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/posts\/3477","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/comments?post=3477"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/posts\/3477\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/media\/3478"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/media?parent=3477"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/categories?post=3477"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/tags?post=3477"}],"curies":[{"name":"\u0648\u0648\u0631\u062f\u0628\u0631\u064a\u0633","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}