{"id":4826,"date":"2025-10-21T14:58:09","date_gmt":"2025-10-21T11:58:09","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=4826"},"modified":"2025-11-01T16:06:07","modified_gmt":"2025-11-01T13:06:07","slug":"why-elevidys-was-not-approved-by-the-european-medicines-agency-ema","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/ar\/why-elevidys-was-not-approved-by-the-european-medicines-agency-ema\/","title":{"rendered":"\u0644\u0645\u0627\u0630\u0627 \u0644\u0645 \u062a\u062a\u0645 \u0627\u0644\u0645\u0648\u0627\u0641\u0642\u0629 \u0639\u0644\u0649 Elevidys \u0645\u0646 \u0642\u0628\u0644 \u0648\u0643\u0627\u0644\u0629 \u0627\u0644\u0623\u062f\u0648\u064a\u0629 \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u0629 (EMA)\u061f"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u0644\u0645 \u062a\u062a\u0645 \u0627\u0644\u0645\u0648\u0627\u0641\u0642\u0629 \u0639\u0644\u0649 \u0627\u0644\u0639\u0644\u0627\u062c \u0627\u0644\u062c\u064a\u0646\u064a Elevidys (\u0627\u0644\u0645\u0627\u062f\u0629 \u0627\u0644\u0641\u0639\u0627\u0644\u0629: \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) \u0645\u0646 \u0642\u0628\u0644 \u0648\u0643\u0627\u0644\u0629 \u0627\u0644\u0623\u062f\u0648\u064a\u0629 \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u0629 (EMA) \u0644\u0639\u0644\u0627\u062c \u0627\u0644\u0623\u0637\u0641\u0627\u0644 \u0627\u0644\u0642\u0627\u062f\u0631\u064a\u0646 \u0639\u0644\u0649 \u0627\u0644\u0645\u0634\u064a \u0627\u0644\u0630\u064a\u0646 \u062a\u062a\u0631\u0627\u0648\u062d \u0623\u0639\u0645\u0627\u0631\u0647\u0645 \u0628\u064a\u0646 3 \u06487 \u0633\u0646\u0648\u0627\u062a \u0648\u0627\u0644\u0630\u064a\u0646 \u064a\u0639\u0627\u0646\u0648\u0646 \u0645\u0646 \u0636\u0645\u0648\u0631 \u0627\u0644\u0639\u0636\u0644\u0627\u062a \u062f\u0648\u0634\u064a\u0646 (DMD) \u0628\u0633\u0628\u0628 \u0627\u0644\u0645\u062e\u0627\u0648\u0641 \u0627\u0644\u0643\u0628\u064a\u0631\u0629 \u0628\u0634\u0623\u0646 \u0641\u0627\u0626\u062f\u062a\u0647 \u0627\u0644\u0645\u062b\u0628\u062a\u0629 \u0641\u064a \u0647\u0630\u0647 \u0627\u0644\u0641\u0626\u0629 \u0645\u0646 \u0627\u0644\u0645\u0631\u0636\u0649.<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/elevidys\" target=\"_blank\" rel=\"noopener\">\u0627\u0644\u0648\u0643\u0627\u0644\u0629 \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u0629 \u0644\u0644\u0623\u062f\u0648\u064a\u0629 (EMA)<\/a>)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0648\u0641\u064a\u0645\u0627 \u064a\u0644\u064a \u0627\u0644\u0623\u0633\u0628\u0627\u0628 \u0627\u0644\u0631\u0626\u064a\u0633\u064a\u0629:<\/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=\"#reasons-for-elevidys-refusal-by-the-ema\">\u0623\u0633\u0628\u0627\u0628 \u0631\u0641\u0636 Elevidys \u0645\u0646 \u0642\u0628\u0644 EMA<\/a><ul><li><a href=\"#additional-context-and-concerns\">\u0627\u0644\u0633\u064a\u0627\u0642 \u0648\u0627\u0644\u0645\u062e\u0627\u0648\u0641 \u0627\u0644\u0625\u0636\u0627\u0641\u064a\u0629<\/a><\/li><li><a href=\"#summary\">\u0645\u0644\u062e\u0635<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"reasons-for-elevidys-refusal-by-the-ema\">\u0623\u0633\u0628\u0627\u0628 \u0631\u0641\u0636 Elevidys \u0645\u0646 \u0642\u0628\u0644 EMA<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u0648\u0641\u0642\u064b\u0627 \u0644\u0644\u062a\u0642\u064a\u064a\u0645 \u0627\u0644\u0639\u0627\u0645 \u0644\u0640 EMA\u060c \u062a\u062a\u0636\u0645\u0646 \u0627\u0644\u0623\u0633\u0628\u0627\u0628 \u0627\u0644\u0645\u062d\u062f\u062f\u0629 \u0645\u0627 \u064a\u0644\u064a:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u0641\u064a \u0627\u0644\u062f\u0631\u0627\u0633\u0629 \u0627\u0644\u0645\u062d\u0648\u0631\u064a\u0629 (\u0648\u0647\u064a \u0627\u0644\u062f\u0644\u064a\u0644 \u0627\u0644\u0631\u0626\u064a\u0633\u064a \u0627\u0644\u0645\u064f\u0642\u062f\u0651\u0645)\u060c \u0644\u0645 \u064a\u064f\u0644\u0627\u062d\u0638 \u0623\u064a \u062a\u062d\u0633\u0646 \u0630\u064a \u062f\u0644\u0627\u0644\u0629 \u0625\u062d\u0635\u0627\u0626\u064a\u0629 \u0641\u064a \u0627\u0644\u0648\u0638\u064a\u0641\u0629 \u0627\u0644\u062d\u0631\u0643\u064a\u0629 (\u0643\u0645\u0627 \u062a\u0645 \u0642\u064a\u0627\u0633\u0647 \u0628\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u062a\u0642\u064a\u064a\u0645 \u0646\u0648\u0631\u062b \u0633\u062a\u0627\u0631 \u0644\u0644\u0645\u0634\u064a (NSAA)) \u0628\u0639\u062f \u0661\u0662 \u0634\u0647\u0631\u064b\u0627 \u0628\u064a\u0646 \u0645\u062c\u0645\u0648\u0639\u0629 Elevidys \u0648\u0645\u062c\u0645\u0648\u0639\u0629 \u0627\u0644\u062f\u0648\u0627\u0621 \u0627\u0644\u0648\u0647\u0645\u064a. \u0643\u0627\u0646 \u0627\u0644\u0641\u0631\u0642 \u0660.\u0666\u0665 \u0646\u0642\u0637\u0629 \u0641\u0642\u0637 \u0639\u0644\u0649 \u0645\u0642\u064a\u0627\u0633 \u0663\u0664 \u0646\u0642\u0637\u0629\u060c \u0648\u0647\u0648 \u0645\u0627 \u062e\u0644\u0635\u062a \u0625\u0644\u064a\u0647 \u0645\u062c\u0645\u0648\u0639\u0629 EMA \u0628\u0623\u0646\u0647 &quot;\u0642\u062f \u064a\u0643\u0648\u0646 \u0646\u062a\u064a\u062c\u0629 \u0644\u0644\u0635\u062f\u0641\u0629&quot;. (<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/elevidys\" target=\"_blank\" rel=\"noreferrer noopener\">\u0627\u0644\u0648\u0643\u0627\u0644\u0629 \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u0629 \u0644\u0644\u0623\u062f\u0648\u064a\u0629 (EMA)<\/a>) <strong>\u0627\u0642\u0631\u0623 \u0627\u0644\u0645\u0632\u064a\u062f<\/strong>: <a href=\"https:\/\/dmdwarrior.com\/ar\/north-star-ambulatory-assessment-nsaa-in-duchenne-dmd\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u0645\u0627 \u0647\u0648 \u062a\u0642\u064a\u064a\u0645 \u0646\u0648\u0631\u062b \u0633\u062a\u0627\u0631 \u0644\u0644\u0645\u0634\u064a\u061f<\/a><\/li>\n\n\n\n<li>\u0648\u0639\u0644\u0649 \u0627\u0644\u0631\u063a\u0645 \u0645\u0646 \u0623\u0646 \u0627\u0644\u0639\u0644\u0627\u062c \u0623\u062f\u0649 \u0625\u0644\u0649 \u0627\u0644\u062a\u0639\u0628\u064a\u0631 \u0639\u0646 \u0634\u0643\u0644 \u0623\u0642\u0635\u0631 \u0645\u0646 \u0628\u0631\u0648\u062a\u064a\u0646 \u0627\u0644\u062f\u064a\u0633\u062a\u0631\u0648\u0641\u064a\u0646\u060c \u0625\u0644\u0627 \u0623\u0646\u0647 \u0644\u0645 \u064a\u0643\u0646 \u0645\u0646 \u0627\u0644\u0645\u0645\u0643\u0646 \u0631\u0628\u0637 \u0645\u0633\u062a\u0648\u064a\u0627\u062a \u0627\u0644\u062a\u0639\u0628\u064a\u0631 \u0639\u0646 \u0647\u0630\u0627 \u0627\u0644\u0628\u0631\u0648\u062a\u064a\u0646 \u0628\u0634\u0643\u0644 \u0645\u0648\u062b\u0648\u0642 \u0628\u062a\u062d\u0633\u064a\u0646\u0627\u062a \u0630\u0627\u062a \u0645\u0639\u0646\u0649 \u0641\u064a \u0627\u0644\u0642\u062f\u0631\u0629 \u0639\u0644\u0649 \u0627\u0644\u062d\u0631\u0643\u0629.<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/elevidys\" target=\"_blank\" rel=\"noreferrer noopener\">\u0627\u0644\u0648\u0643\u0627\u0644\u0629 \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u0629 \u0644\u0644\u0623\u062f\u0648\u064a\u0629 (EMA)<\/a>)<\/li>\n\n\n\n<li>\u0648\u062d\u062a\u0649 \u0639\u0646\u062f \u0627\u0644\u0646\u0638\u0631 \u0641\u064a \u0645\u062c\u0645\u0648\u0639\u0627\u062a \u0641\u0631\u0639\u064a\u0629 \u0645\u0646 \u0627\u0644\u0645\u0631\u0636\u0649 \u0627\u0644\u0630\u064a\u0646 \u0628\u062f\u0627 \u0623\u0646\u0647\u0645 \u064a\u0633\u062a\u062c\u064a\u0628\u0648\u0646 \u0628\u0634\u0643\u0644 \u0623\u0641\u0636\u0644\u060c \u0644\u0645 \u062a\u062a\u0645\u0643\u0646 \u0627\u0644\u0634\u0631\u0643\u0629 \u0645\u0646 \u0625\u062b\u0628\u0627\u062a \u0628\u0634\u0643\u0644 \u0645\u0642\u0646\u0639 \u0623\u0646 \u0627\u0644\u0639\u0644\u0627\u062c \u0642\u062f\u0645 \u0641\u0627\u0626\u062f\u0629 \u0630\u0627\u062a \u0645\u0639\u0646\u0649 \u0633\u0631\u064a\u0631\u064a \u0641\u064a \u062a\u0644\u0643 \u0627\u0644\u0645\u062c\u0645\u0648\u0639\u0627\u062a \u0623\u064a\u0636\u064b\u0627. (<a href=\"https:\/\/www.institut-myologie.org\/en\/2025\/09\/22\/unfavorable-opinion-on-marketing-authorisation-and-suspension-of-clinical-trials-in-europe-for-elevidys-in-duchenne-muscular-dystrophy\/\" target=\"_blank\" rel=\"noreferrer noopener\">institut-myologie.org<\/a>)<\/li>\n\n\n\n<li>\u0644\u0623\u0646 \u0627\u0644\u0634\u0631\u0643\u0629 \u062a\u0642\u062f\u0645\u062a \u0628\u0637\u0644\u0628 \u0644\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u062a\u0631\u062e\u064a\u0635 \u062a\u0633\u0648\u064a\u0642 \u0645\u0634\u0631\u0648\u0637 (CMA)\u060c \u0641\u0625\u0646 \u0627\u0644\u0645\u0639\u064a\u0627\u0631 \u0627\u0644\u0630\u064a \u064a\u0637\u0628\u0642\u0647 EMA \u0647\u0648 \u0648\u062c\u0648\u0628 \u0648\u062c\u0648\u062f \u0641\u0627\u0626\u062f\u0629\/\u0645\u062e\u0627\u0637\u0631\u0629 \u0625\u064a\u062c\u0627\u0628\u064a\u0629 (\u0623\u064a \u062f\u0644\u064a\u0644 \u0639\u0644\u0649 \u0641\u0627\u0626\u062f\u0629 + \u0645\u062e\u0627\u0637\u0631\u0629 \u064a\u0645\u0643\u0646 \u0625\u062f\u0627\u0631\u062a\u0647\u0627) \u0645\u0639 \u0628\u0639\u0636 \u0627\u0644\u0628\u064a\u0627\u0646\u0627\u062a \u0627\u0644\u0645\u0642\u0646\u0639\u0629 \u0627\u0644\u062a\u064a \u062a\u062f\u0639\u0645\u0647\u0627. \u062e\u0644\u0635 EMA \u0625\u0644\u0649 \u0623\u0646 \u0627\u0644\u0641\u0648\u0627\u0626\u062f \u0644\u0645 \u062a\u064f\u062b\u0628\u062a \u0628\u0634\u0643\u0644 \u0643\u0627\u0641\u064d \u0641\u064a \u0647\u0630\u0627 \u0627\u0644\u0633\u064a\u0627\u0642\u060c \u0648\u0644\u0630\u0644\u0643 \u0631\u0641\u0636 \u0627\u0644\u062a\u0631\u062e\u064a\u0635.<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/elevidys\" target=\"_blank\" rel=\"noreferrer noopener\">\u0627\u0644\u0648\u0643\u0627\u0644\u0629 \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u0629 \u0644\u0644\u0623\u062f\u0648\u064a\u0629 (EMA)<\/a>)<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"additional-context-and-concerns\">\u0627\u0644\u0633\u064a\u0627\u0642 \u0648\u0627\u0644\u0645\u062e\u0627\u0648\u0641 \u0627\u0644\u0625\u0636\u0627\u0641\u064a\u0629<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u0642\u0636\u0627\u064a\u0627 \u0627\u0644\u0633\u0644\u0627\u0645\u0629: \u0643\u0627\u0646\u062a \u0647\u0646\u0627\u0643 \u0623\u064a\u0636\u064b\u0627 \u0645\u062e\u0627\u0648\u0641 \u0643\u0628\u064a\u0631\u0629 \u062a\u062a\u0639\u0644\u0642 \u0628\u0627\u0644\u0633\u0644\u0627\u0645\u0629\u060c \u062e\u0627\u0635\u0629\u064b \u0644\u062f\u0649 \u0627\u0644\u0645\u0631\u0636\u0649 \u063a\u064a\u0631 \u0627\u0644\u0642\u0627\u062f\u0631\u064a\u0646 \u0639\u0644\u0649 \u0627\u0644\u0645\u0634\u064a. \u0633\u064f\u062c\u0650\u0651\u0644\u062a \u0639\u062f\u0629 \u0648\u0641\u064a\u0627\u062a \u0646\u0627\u062c\u0645\u0629 \u0639\u0646 \u0641\u0634\u0644 \u0627\u0644\u0643\u0628\u062f \u0627\u0644\u062d\u0627\u062f \u0644\u062f\u0649 \u0627\u0644\u0645\u0631\u0636\u0649 \u063a\u064a\u0631 \u0627\u0644\u0642\u0627\u062f\u0631\u064a\u0646 \u0639\u0644\u0649 \u0627\u0644\u0645\u0634\u064a \u0627\u0644\u0630\u064a\u0646 \u062a\u0644\u0642\u0648\u0627 Elevidys\u060c \u0648\u0642\u062f \u0623\u064f\u0648\u0642\u0650\u0641\u064e\u062a \u0627\u0644\u062a\u062c\u0627\u0631\u0628 \u0627\u0644\u0633\u0631\u064a\u0631\u064a\u0629 \u0639\u0644\u0649 \u0647\u0630\u0647 \u0627\u0644\u0641\u0626\u0629 \u0645\u0646 \u0627\u0644\u0645\u0631\u0636\u0649 \u0645\u0624\u0642\u062a\u064b\u0627.<a href=\"https:\/\/dmdwarrior.com\/ar\/aan-report-reviews-the-state-of-evidence-on-elevidys-gene-therapy-cure-for-duchenne-muscular-dystrophy\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u062f\u064a \u0627\u0645 \u062f\u064a \u0648\u0627\u0631\u064a\u0648 \u0627\u0631<\/a>) \u0641\u064a \u062d\u064a\u0646 \u0623\u0646 \u0631\u0641\u0636 EMA \u0643\u0627\u0646 \u0641\u064a \u0627\u0644\u0645\u0642\u0627\u0645 \u0627\u0644\u0623\u0648\u0644 \u0639\u0644\u0649 \u0623\u0633\u0633 \u062a\u062a\u0639\u0644\u0642 \u0628\u0627\u0644\u0641\u0639\u0627\u0644\u064a\u0629 \u0628\u0627\u0644\u0646\u0633\u0628\u0629 \u0644\u0644\u0623\u0637\u0641\u0627\u0644 \u0627\u0644\u0642\u0627\u062f\u0631\u064a\u0646 \u0639\u0644\u0649 \u0627\u0644\u0645\u0634\u064a \u0627\u0644\u0630\u064a\u0646 \u062a\u062a\u0631\u0627\u0648\u062d \u0623\u0639\u0645\u0627\u0631\u0647\u0645 \u0628\u064a\u0646 3 \u06487 \u0633\u0646\u0648\u0627\u062a\u060c \u0641\u0645\u0646 \u0627\u0644\u0645\u0631\u062c\u062d \u0623\u0646 \u0625\u0634\u0627\u0631\u0629 \u0627\u0644\u0633\u0644\u0627\u0645\u0629 \u0643\u0627\u0646 \u0644\u0647\u0627 \u062a\u0623\u062b\u064a\u0631 \u0639\u0644\u0649 \u0627\u0644\u0628\u064a\u0626\u0629 \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a\u0629 \u0627\u0644\u0634\u0627\u0645\u0644\u0629.<\/li>\n\n\n\n<li>\u0643\u0627\u0646 \u0627\u0644\u0637\u0644\u0628 \u0627\u0644\u0645\u0642\u062f\u0645 \u0625\u0644\u0649 EMA \u0645\u062e\u0635\u0635\u064b\u0627 \u0644\u0645\u0631\u0636\u0649 \u0642\u0627\u062f\u0631\u064a\u0646 \u0639\u0644\u0649 \u0627\u0644\u0645\u0634\u064a \u062a\u062a\u0631\u0627\u0648\u062d \u0623\u0639\u0645\u0627\u0631\u0647\u0645 \u0628\u064a\u0646 3 \u06487 \u0633\u0646\u0648\u0627\u062a. \u0648\u0642\u062f \u0627\u0639\u062a\u0628\u0631\u062a EMA \u0623\u0646 \u062a\u0635\u0645\u064a\u0645 \u0627\u0644\u062a\u062c\u0631\u0628\u0629 \u0648\u0627\u062e\u062a\u064a\u0627\u0631 \u0646\u0642\u0637\u0629 \u0627\u0644\u0646\u0647\u0627\u064a\u0629 \u0627\u0644\u0623\u0633\u0627\u0633\u064a\u0629 (\u062a\u063a\u064a\u064a\u0631 12 \u0634\u0647\u0631\u064b\u0627 \u0641\u064a NSAA) \u063a\u064a\u0631 \u0643\u0627\u0641\u064a\u064a\u0646 \u0644\u0625\u062b\u0628\u0627\u062a \u062a\u0628\u0627\u0637\u0624 \u0645\u0644\u062d\u0648\u0638 \u0641\u064a \u062a\u0637\u0648\u0631 \u0627\u0644\u0645\u0631\u0636 \u0641\u064a \u062a\u0644\u0643 \u0627\u0644\u0645\u062c\u0645\u0648\u0639\u0629.<a href=\"https:\/\/www.institut-myologie.org\/en\/2025\/09\/22\/unfavorable-opinion-on-marketing-authorisation-and-suspension-of-clinical-trials-in-europe-for-elevidys-in-duchenne-muscular-dystrophy\/\" target=\"_blank\" rel=\"noreferrer noopener\">institut-myologie.org<\/a>)<\/li>\n\n\n\n<li>\u0648\u0642\u062f \u062a\u0645\u062a \u0627\u0644\u0645\u0648\u0627\u0641\u0642\u0629 \u0639\u0644\u0649 \u0627\u0644\u0639\u0644\u0627\u062c \u0641\u064a \u0628\u0639\u0636 \u0627\u0644\u0645\u0646\u0627\u0637\u0642 \u0627\u0644\u0623\u062e\u0631\u0649 (\u0645\u062b\u0644 \u0627\u0644\u064a\u0627\u0628\u0627\u0646 \u0648\u0628\u0639\u0636 \u0628\u0644\u062f\u0627\u0646 \u0627\u0644\u0634\u0631\u0642 \u0627\u0644\u0623\u0648\u0633\u0637) \u0641\u064a \u0638\u0644 \u0623\u0637\u0631 \u062a\u0646\u0638\u064a\u0645\u064a\u0629 \u0645\u062e\u062a\u0644\u0641\u0629.<a href=\"https:\/\/dmdwarrior.com\/ar\/in-which-countries-is-elevidys-approved-is-elevidys-approved-\/\" target=\"_blank\" rel=\"noreferrer noopener\">dmdwarrior.com<\/a>)<\/li>\n\n\n\n<li>\u0625\u0646 \u0631\u0623\u064a EMA (\u0639\u0628\u0631 \u0644\u062c\u0646\u0629 \u0627\u0644\u0645\u0646\u062a\u062c\u0627\u062a \u0627\u0644\u0637\u0628\u064a\u0629 \u0644\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0627\u0644\u0628\u0634\u0631\u064a\u060c CHMP) \u0644\u064a\u0633 \u0645\u0644\u0632\u0645\u0627\u064b \u0642\u0627\u0646\u0648\u0646\u0627\u064b \u062d\u062a\u0649 \u0642\u0631\u0627\u0631 \u0627\u0644\u0645\u0641\u0648\u0636\u064a\u0629 \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u0629\u060c \u0648\u0644\u0643\u0646 \u0641\u064a \u0627\u0644\u0645\u0645\u0627\u0631\u0633\u0629 \u0627\u0644\u0639\u0645\u0644\u064a\u0629 \u0641\u0625\u0646 \u0622\u0631\u0627\u0621 CHMP \u0627\u0644\u0633\u0644\u0628\u064a\u0629 \u062a\u0624\u062f\u064a \u062f\u0627\u0626\u0645\u0627\u064b \u062a\u0642\u0631\u064a\u0628\u0627\u064b \u0625\u0644\u0649 \u0627\u0644\u0631\u0641\u0636.<a href=\"https:\/\/www.globenewswire.com\/de\/news-release\/2025\/08\/11\/3131260\/32716\/en\/sarepta-therapeutics-srpt-declines-again-on-ema-recommendation-to-refuse-elevidys-marketing-authorization-securities-class-action-pending-hagens-berman.html\" target=\"_blank\" rel=\"noreferrer noopener\">\u062c\u0644\u0648\u0628 \u0646\u064a\u0648\u0632\u0648\u0627\u064a\u0631<\/a>)<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"summary\">\u0645\u0644\u062e\u0635<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u0639\u0644\u0649 \u0627\u0644\u0631\u063a\u0645 \u0645\u0646 \u0623\u0646 Elevidys \u064a\u0645\u062b\u0644 \u0646\u0647\u062c\u064b\u0627 \u0639\u0644\u0627\u062c\u064a\u064b\u0627 \u062c\u064a\u0646\u064a\u064b\u0627 \u062c\u062f\u064a\u062f\u064b\u0627 \u0644\u0636\u0645\u0648\u0631 \u0627\u0644\u0639\u0636\u0644\u0627\u062a \u0627\u0644\u062f\u0648\u0634\u064a\u0646\u064a\u060c \u0625\u0644\u0627 \u0623\u0646 EMA \u062e\u0644\u0635 \u0625\u0644\u0649 \u0623\u0646 \u0627\u0644\u0623\u062f\u0644\u0629 \u0627\u0644\u0645\u0642\u062f\u0645\u0629 \u0644\u0645 \u062a\u062b\u0628\u062a \u0628\u0634\u0643\u0644 \u0643\u0627\u0641\u064d \u0623\u0646\u0647 \u064a\u064f\u062d\u0633\u0651\u0646 \u0627\u0644\u0648\u0638\u0627\u0626\u0641 \u0627\u0644\u062d\u0631\u0643\u064a\u0629 \u0644\u062f\u0649 \u0627\u0644\u0623\u0637\u0641\u0627\u0644 \u0627\u0644\u0645\u0633\u062a\u0647\u062f\u0641\u064a\u0646 \u0627\u0644\u0642\u0627\u062f\u0631\u064a\u0646 \u0639\u0644\u0649 \u0627\u0644\u0645\u0634\u064a (\u0645\u0646 3 \u0625\u0644\u0649 7 \u0633\u0646\u0648\u0627\u062a)\u060c \u0648\u0623\u0646 \u0646\u0633\u0628\u0629 \u0627\u0644\u0641\u0627\u0626\u062f\u0629 \u0625\u0644\u0649 \u0627\u0644\u0645\u062e\u0627\u0637\u0631 \u0644\u0645 \u062a\u064f\u062d\u062f\u062f \u0644\u0647\u0630\u0647 \u0627\u0644\u0641\u0626\u0629. \u0644\u0630\u0644\u0643\u060c \u0623\u0648\u0635\u0648\u0627 \u0628\u0631\u0641\u0636 \u062a\u0631\u062e\u064a\u0635 \u0627\u0644\u062a\u0633\u0648\u064a\u0642.<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/elevidys\" target=\"_blank\" rel=\"noreferrer noopener\">\u0627\u0644\u0648\u0643\u0627\u0644\u0629 \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u0629 \u0644\u0644\u0623\u062f\u0648\u064a\u0629 (EMA)<\/a>)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u0627\u0642\u0631\u0623 \u0627\u0644\u0645\u0632\u064a\u062f<\/strong>: <a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/assessment-report\/elevidys-epar-refusal-public-assessment-report_en.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">\u064a\u0645\u0643\u0646\u0643\u0645 \u0627\u0644\u0627\u0637\u0644\u0627\u0639 \u0639\u0644\u0649 \u0627\u0644\u062a\u0642\u0631\u064a\u0631 \u0627\u0644\u0634\u0627\u0645\u0644 \u062d\u0648\u0644 \u0623\u0633\u0628\u0627\u0628 \u0631\u0641\u0636 Elevidys \u0627\u0644\u0630\u064a \u0646\u0634\u0631\u062a\u0647 EMA \u0645\u0646 \u0647\u0630\u0627 \u0627\u0644\u0631\u0627\u0628\u0637.<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>The Elevidys (active substance: delandistrogene\u202fmoxeparvovec) gene therapy was not approved by the European Medicines Agency (EMA) for the treatment of ambulatory children aged 3\u20117 years with Duchenne\u202fmuscular\u202fdystrophy (DMD) because of significant concerns about its demonstrated benefit in that patient population. (European Medicines Agency (EMA)) Here are the key reasons: Reasons for Elevidys&#8217; Refusal by the [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":4833,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[282],"tags":[121,33,61,65],"class_list":["post-4826","post","type-post","status-publish","format-standard","has-post-thumbnail","category-editorials","tag-delandistrogene-moxeparvovec","tag-elevidys","tag-gene-therapy","tag-sarepta"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/posts\/4826","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=4826"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/posts\/4826\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/media\/4833"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/media?parent=4826"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/categories?post=4826"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/tags?post=4826"}],"curies":[{"name":"\u0648\u0648\u0631\u062f\u0628\u0631\u064a\u0633","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}