{"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\/hi\/why-elevidys-was-not-approved-by-the-european-medicines-agency-ema\/","title":{"rendered":"Elevidys \u0915\u094b \u092f\u0942\u0930\u094b\u092a\u0940\u092f \u091a\u093f\u0915\u093f\u0924\u094d\u0938\u093e \u090f\u091c\u0947\u0902\u0938\u0940 (EMA) \u0926\u094d\u0935\u093e\u0930\u093e \u0905\u0928\u0941\u092e\u094b\u0926\u093f\u0924 \u0915\u094d\u092f\u094b\u0902 \u0928\u0939\u0940\u0902 \u0915\u093f\u092f\u093e \u0917\u092f\u093e?"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Elevidys (\u0938\u0915\u094d\u0930\u093f\u092f \u092a\u0926\u093e\u0930\u094d\u0925: \u0921\u0947\u0932\u0948\u0902\u0921\u093f\u0938\u094d\u091f\u094d\u0930\u094b\u091c\u0940\u0928 \u092e\u094b\u0915\u094d\u0938\u0947\u092a\u093e\u0930\u094d\u0935\u094b\u0935\u0947\u0915) \u091c\u0940\u0928 \u0925\u0947\u0930\u0947\u092a\u0940 \u0915\u094b \u0921\u094d\u092f\u0942\u091a\u0947\u0928 \u092e\u0938\u094d\u0915\u0941\u0932\u0930 \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u0949\u092b\u0940 (\u0921\u0940\u090f\u092e\u0921\u0940) \u0938\u0947 \u092a\u0940\u0921\u093c\u093f\u0924 3-7 \u0935\u0930\u094d\u0937 \u0915\u0940 \u0906\u092f\u0941 \u0915\u0947 \u091a\u0932\u0928\u0947-\u092b\u093f\u0930\u0928\u0947 \u092e\u0947\u0902 \u0938\u0915\u094d\u0937\u092e \u092c\u091a\u094d\u091a\u094b\u0902 \u0915\u0947 \u0909\u092a\u091a\u093e\u0930 \u0915\u0947 \u0932\u093f\u090f \u092f\u0942\u0930\u094b\u092a\u0940\u092f \u092e\u0947\u0921\u093f\u0938\u093f\u0928 \u090f\u091c\u0947\u0902\u0938\u0940 (EMA) \u0926\u094d\u0935\u093e\u0930\u093e \u0905\u0928\u0941\u092e\u094b\u0926\u093f\u0924 \u0928\u0939\u0940\u0902 \u0915\u093f\u092f\u093e \u0917\u092f\u093e \u0925\u093e, \u0915\u094d\u092f\u094b\u0902\u0915\u093f \u0909\u0938 \u0930\u094b\u0917\u0940 \u0938\u092e\u0942\u0939 \u092e\u0947\u0902 \u0907\u0938\u0915\u0947 \u092a\u094d\u0930\u0926\u0930\u094d\u0936\u093f\u0924 \u0932\u093e\u092d \u0915\u0947 \u092c\u093e\u0930\u0947 \u092e\u0947\u0902 \u092e\u0939\u0924\u094d\u0935\u092a\u0942\u0930\u094d\u0923 \u091a\u093f\u0902\u0924\u093e\u090f\u0902 \u0925\u0940\u0902\u0964<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/elevidys\" target=\"_blank\" rel=\"noopener\">\u092f\u0942\u0930\u094b\u092a\u0940\u092f \u0914\u0937\u0927\u093f \u090f\u091c\u0947\u0902\u0938\u0940 (EMA)<\/a>)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0907\u0938\u0915\u0947 \u092a\u094d\u0930\u092e\u0941\u0916 \u0915\u093e\u0930\u0923 \u0907\u0938 \u092a\u094d\u0930\u0915\u093e\u0930 \u0939\u0948\u0902:<\/p>\n\n\n\n<div class=\"wp-block-rank-math-toc-block\" id=\"rank-math-toc\"><h2>\u0935\u093f\u0937\u092f\u0938\u0942\u091a\u0940<\/h2><nav><ul><li><a href=\"#reasons-for-elevidys-refusal-by-the-ema\">EMA \u0926\u094d\u0935\u093e\u0930\u093e Elevidys \u0915\u0947 \u0907\u0928\u0915\u093e\u0930 \u0915\u0947 \u0915\u093e\u0930\u0923<\/a><ul><li><a href=\"#additional-context-and-concerns\">\u0905\u0924\u093f\u0930\u093f\u0915\u094d\u0924 \u0938\u0902\u0926\u0930\u094d\u092d \u0914\u0930 \u091a\u093f\u0902\u0924\u093e\u090f\u0901<\/a><\/li><li><a href=\"#summary\">\u0938\u093e\u0930\u093e\u0902\u0936<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"reasons-for-elevidys-refusal-by-the-ema\">EMA \u0926\u094d\u0935\u093e\u0930\u093e Elevidys \u0915\u0947 \u0907\u0928\u0915\u093e\u0930 \u0915\u0947 \u0915\u093e\u0930\u0923<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>EMA \u0915\u0947 \u0938\u093e\u0930\u094d\u0935\u091c\u0928\u093f\u0915 \u092e\u0942\u0932\u094d\u092f\u093e\u0902\u0915\u0928 \u0915\u0947 \u0905\u0928\u0941\u0938\u093e\u0930 \u0935\u093f\u0936\u093f\u0937\u094d\u091f \u0915\u093e\u0930\u0923\u094b\u0902 \u092e\u0947\u0902 \u0936\u093e\u092e\u093f\u0932 \u0939\u0948\u0902:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u0928\u093f\u0930\u094d\u0923\u093e\u092f\u0915 \u0905\u0927\u094d\u092f\u092f\u0928 (\u092a\u094d\u0930\u0938\u094d\u0924\u0941\u0924 \u092e\u0941\u0916\u094d\u092f \u0938\u093e\u0915\u094d\u0937\u094d\u092f) \u092e\u0947\u0902, Elevidys \u0938\u092e\u0942\u0939 \u0914\u0930 \u092a\u094d\u0932\u0947\u0938\u0940\u092c\u094b \u0938\u092e\u0942\u0939 \u0915\u0947 \u092c\u0940\u091a 12 \u092e\u0939\u0940\u0928\u094b\u0902 \u092e\u0947\u0902 \u092e\u094b\u091f\u0930-\u092b\u093c\u0902\u0915\u094d\u0936\u0928 (\u0928\u0949\u0930\u094d\u0925 \u0938\u094d\u091f\u093e\u0930 \u090f\u092e\u094d\u092c\u0941\u0932\u0947\u091f\u0930\u0940 \u0905\u0938\u0947\u0938\u092e\u0947\u0902\u091f, NSAA \u0915\u093e \u0909\u092a\u092f\u094b\u0917 \u0915\u0930\u0915\u0947 \u092e\u093e\u092a\u093e \u0917\u092f\u093e) \u092e\u0947\u0902 \u0915\u094b\u0908 \u0938\u093e\u0902\u0916\u094d\u092f\u093f\u0915\u0940\u092f \u0930\u0942\u092a \u0938\u0947 \u092e\u0939\u0924\u094d\u0935\u092a\u0942\u0930\u094d\u0923 \u0938\u0941\u0927\u093e\u0930 \u0928\u0939\u0940\u0902 \u0926\u0947\u0916\u093e \u0917\u092f\u093e\u0964 34-\u092c\u093f\u0902\u0926\u0941 \u092a\u0948\u092e\u093e\u0928\u0947 \u092a\u0930 \u092f\u0939 \u0905\u0902\u0924\u0930 \u0915\u0947\u0935\u0932 0.65 \u0905\u0902\u0915 \u0915\u093e \u0925\u093e, \u091c\u093f\u0938\u0915\u0947 \u092c\u093e\u0930\u0947 \u092e\u0947\u0902 EMA \u0928\u0947 \u0928\u093f\u0937\u094d\u0915\u0930\u094d\u0937 \u0928\u093f\u0915\u093e\u0932\u093e \u0915\u093f &quot;\u092f\u0939 \u0938\u0902\u092f\u094b\u0917\u0935\u0936 \u0939\u094b \u0938\u0915\u0924\u093e \u0939\u0948&quot;\u0964<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/elevidys\" target=\"_blank\" rel=\"noreferrer noopener\">\u092f\u0942\u0930\u094b\u092a\u0940\u092f \u0914\u0937\u0927\u093f \u090f\u091c\u0947\u0902\u0938\u0940 (EMA)<\/a>) <strong>\u0914\u0930 \u092a\u0922\u093c\u0947\u0902<\/strong>: <a href=\"https:\/\/dmdwarrior.com\/hi\/north-star-ambulatory-assessment-nsaa-in-duchenne-dmd\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u0928\u0949\u0930\u094d\u0925 \u0938\u094d\u091f\u093e\u0930 \u090f\u092e\u094d\u092c\u0941\u0932\u0947\u091f\u0930\u0940 \u0905\u0938\u0947\u0938\u092e\u0947\u0902\u091f \u0915\u094d\u092f\u093e \u0939\u0948?<\/a><\/li>\n\n\n\n<li>\u092f\u0926\u094d\u092f\u092a\u093f \u091a\u093f\u0915\u093f\u0924\u094d\u0938\u093e \u0928\u0947 \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u094b\u092b\u093f\u0928 \u092a\u094d\u0930\u094b\u091f\u0940\u0928 \u0915\u0947 \u090f\u0915 \u091b\u094b\u091f\u0947 \u0930\u0942\u092a \u0915\u0940 \u0905\u092d\u093f\u0935\u094d\u092f\u0915\u094d\u0924\u093f \u0915\u094b \u092a\u094d\u0930\u0947\u0930\u093f\u0924 \u0915\u093f\u092f\u093e, \u0932\u0947\u0915\u093f\u0928 \u0909\u0938 \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u094b\u092b\u093f\u0928 \u0905\u092d\u093f\u0935\u094d\u092f\u0915\u094d\u0924\u093f \u0915\u0947 \u0938\u094d\u0924\u0930 \u0915\u094b \u0917\u0924\u093f\u0936\u0940\u0932\u0924\u093e \u0915\u094d\u0937\u092e\u0924\u093e \u092e\u0947\u0902 \u0938\u093e\u0930\u094d\u0925\u0915 \u0938\u0941\u0927\u093e\u0930 \u0915\u0947 \u0938\u093e\u0925 \u0935\u093f\u0936\u094d\u0935\u0938\u0928\u0940\u092f \u0930\u0942\u092a \u0938\u0947 \u0928\u0939\u0940\u0902 \u091c\u094b\u0921\u093c\u093e \u091c\u093e \u0938\u0915\u093e\u0964<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/elevidys\" target=\"_blank\" rel=\"noreferrer noopener\">\u092f\u0942\u0930\u094b\u092a\u0940\u092f \u0914\u0937\u0927\u093f \u090f\u091c\u0947\u0902\u0938\u0940 (EMA)<\/a>)<\/li>\n\n\n\n<li>\u092f\u0939\u093e\u0902 \u0924\u0915 \u0915\u093f \u0909\u0928 \u0930\u094b\u0917\u093f\u092f\u094b\u0902 \u0915\u0947 \u0909\u092a-\u0938\u092e\u0942\u0939\u094b\u0902 \u092a\u0930 \u0935\u093f\u091a\u093e\u0930 \u0915\u0930\u0924\u0947 \u0938\u092e\u092f \u092d\u0940, \u091c\u094b \u092c\u0947\u0939\u0924\u0930 \u092a\u094d\u0930\u0924\u093f\u0915\u094d\u0930\u093f\u092f\u093e \u0926\u0947\u0924\u0947 \u092a\u094d\u0930\u0924\u0940\u0924 \u0939\u0941\u090f, \u0915\u0902\u092a\u0928\u0940 \u092f\u0939 \u0938\u094d\u092a\u0937\u094d\u091f \u0930\u0942\u092a \u0938\u0947 \u0928\u0939\u0940\u0902 \u0926\u093f\u0916\u093e \u0938\u0915\u0940 \u0915\u093f \u0909\u092a\u091a\u093e\u0930 \u0928\u0947 \u0909\u0928 \u0938\u092e\u0942\u0939\u094b\u0902 \u092e\u0947\u0902 \u092d\u0940 \u091a\u093f\u0915\u093f\u0924\u094d\u0938\u0915\u0940\u092f \u0930\u0942\u092a \u0938\u0947 \u0938\u093e\u0930\u094d\u0925\u0915 \u0932\u093e\u092d \u092a\u094d\u0930\u0926\u093e\u0928 \u0915\u093f\u092f\u093e\u0964<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>\u091a\u0942\u0901\u0915\u093f \u0915\u0902\u092a\u0928\u0940 \u0928\u0947 \u0938\u0936\u0930\u094d\u0924 \u0935\u093f\u092a\u0923\u0928 \u092a\u094d\u0930\u093e\u0927\u093f\u0915\u0930\u0923 (\u0938\u0940\u090f\u092e\u090f) \u0915\u0947 \u0932\u093f\u090f \u0906\u0935\u0947\u0926\u0928 \u0915\u093f\u092f\u093e \u0925\u093e, \u0907\u0938\u0932\u093f\u090f EMA \u0926\u094d\u0935\u093e\u0930\u093e \u0932\u093e\u0917\u0942 \u092e\u093e\u0928\u0915 \u092f\u0939 \u0939\u0948 \u0915\u093f \u0938\u0915\u093e\u0930\u093e\u0924\u094d\u092e\u0915 \u0932\u093e\u092d-\u091c\u094b\u0916\u093f\u092e (\u0905\u0930\u094d\u0925\u093e\u0924, \u0932\u093e\u092d \u0915\u093e \u092a\u094d\u0930\u092e\u093e\u0923 + \u092a\u094d\u0930\u092c\u0902\u0927\u0928\u0940\u092f \u091c\u094b\u0916\u093f\u092e) \u0939\u094b\u0928\u093e \u091a\u093e\u0939\u093f\u090f \u0914\u0930 \u0907\u0938\u0915\u0947 \u0938\u092e\u0930\u094d\u0925\u0928 \u092e\u0947\u0902 \u0915\u0941\u091b \u0920\u094b\u0938 \u0906\u0901\u0915\u0921\u093c\u0947 \u0939\u094b\u0928\u0947 \u091a\u093e\u0939\u093f\u090f\u0964 EMA \u0928\u0947 \u0928\u093f\u0937\u094d\u0915\u0930\u094d\u0937 \u0928\u093f\u0915\u093e\u0932\u093e \u0915\u093f \u0907\u0938 \u0938\u0902\u0926\u0930\u094d\u092d \u092e\u0947\u0902 \u0932\u093e\u092d\u094b\u0902 \u0915\u094b \u092a\u0930\u094d\u092f\u093e\u092a\u094d\u0924 \u0930\u0942\u092a \u0938\u0947 \u092a\u094d\u0930\u0926\u0930\u094d\u0936\u093f\u0924 \u0928\u0939\u0940\u0902 \u0915\u093f\u092f\u093e \u0917\u092f\u093e \u0939\u0948, \u0914\u0930 \u0907\u0938\u0932\u093f\u090f \u092a\u094d\u0930\u093e\u0927\u093f\u0915\u0930\u0923 \u0926\u0947\u0928\u0947 \u0938\u0947 \u0907\u0928\u0915\u093e\u0930 \u0915\u0930 \u0926\u093f\u092f\u093e\u0964<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/elevidys\" target=\"_blank\" rel=\"noreferrer noopener\">\u092f\u0942\u0930\u094b\u092a\u0940\u092f \u0914\u0937\u0927\u093f \u090f\u091c\u0947\u0902\u0938\u0940 (EMA)<\/a>)<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"additional-context-and-concerns\">\u0905\u0924\u093f\u0930\u093f\u0915\u094d\u0924 \u0938\u0902\u0926\u0930\u094d\u092d \u0914\u0930 \u091a\u093f\u0902\u0924\u093e\u090f\u0901<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u0938\u0941\u0930\u0915\u094d\u0937\u093e \u0938\u0902\u092c\u0902\u0927\u0940 \u092e\u0941\u0926\u094d\u0926\u0947: \u0935\u093f\u0936\u0947\u0937 \u0930\u0942\u092a \u0938\u0947 \u091a\u0932\u0928\u0947-\u092b\u093f\u0930\u0928\u0947 \u092e\u0947\u0902 \u0905\u0938\u092e\u0930\u094d\u0925 \u0930\u094b\u0917\u093f\u092f\u094b\u0902 \u092e\u0947\u0902, \u0938\u0941\u0930\u0915\u094d\u0937\u093e \u0938\u0902\u092c\u0902\u0927\u0940 \u0917\u0902\u092d\u0940\u0930 \u091a\u093f\u0902\u0924\u093e\u090f\u0901 \u092d\u0940 \u0925\u0940\u0902\u0964 Elevidys \u092a\u094d\u0930\u093e\u092a\u094d\u0924 \u0915\u0930\u0928\u0947 \u0935\u093e\u0932\u0947 \u091a\u0932\u0928\u0947-\u092b\u093f\u0930\u0928\u0947 \u092e\u0947\u0902 \u0905\u0938\u092e\u0930\u094d\u0925 \u0930\u094b\u0917\u093f\u092f\u094b\u0902 \u092e\u0947\u0902 \u0924\u0940\u0935\u094d\u0930 \u092f\u0915\u0943\u0924 \u0935\u093f\u092b\u0932\u0924\u093e \u0938\u0947 \u0915\u0908 \u092e\u094c\u0924\u0947\u0902 \u0926\u0930\u094d\u091c \u0915\u0940 \u0917\u0908\u0902, \u0907\u0938\u0932\u093f\u090f \u0909\u0938 \u0938\u092e\u0942\u0939 \u092e\u0947\u0902 \u092a\u0930\u0940\u0915\u094d\u0937\u0923 \u0930\u094b\u0915 \u0926\u093f\u090f \u0917\u090f\u0964<a href=\"https:\/\/dmdwarrior.com\/hi\/aan-report-reviews-the-state-of-evidence-on-elevidys-gene-therapy-cure-for-duchenne-muscular-dystrophy\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u0921\u0940\u090f\u092e\u0921\u0940\u0935\u0949\u0930\u093f\u092f\u094b\u0906\u0930<\/a>) \u091c\u092c\u0915\u093f EMA \u0926\u094d\u0935\u093e\u0930\u093e \u0907\u0928\u0915\u093e\u0930 \u092e\u0941\u0916\u094d\u092f \u0930\u0942\u092a \u0938\u0947 3-7 \u0935\u0930\u094d\u0937 \u0915\u0940 \u0906\u092f\u0941 \u0915\u0947 \u091a\u0932\u0928\u0947-\u092b\u093f\u0930\u0928\u0947 \u092e\u0947\u0902 \u0938\u0915\u094d\u0937\u092e \u0932\u094b\u0917\u094b\u0902 \u0915\u0947 \u0932\u093f\u090f \u092a\u094d\u0930\u092d\u093e\u0935\u0915\u093e\u0930\u093f\u0924\u093e \u0915\u0947 \u0906\u0927\u093e\u0930 \u092a\u0930 \u0915\u093f\u092f\u093e \u0917\u092f\u093e \u0925\u093e, \u0938\u0941\u0930\u0915\u094d\u0937\u093e \u0938\u0902\u0915\u0947\u0924 \u0928\u0947 \u0938\u0902\u092d\u0935\u0924\u0903 \u0938\u092e\u0917\u094d\u0930 \u0935\u093f\u0928\u093f\u092f\u093e\u092e\u0915 \u0935\u093e\u0924\u093e\u0935\u0930\u0923 \u0915\u094b \u092a\u094d\u0930\u092d\u093e\u0935\u093f\u0924 \u0915\u093f\u092f\u093e\u0964.<\/li>\n\n\n\n<li>EMA \u0915\u094b \u092a\u094d\u0930\u0938\u094d\u0924\u0941\u0924 \u0906\u0935\u0947\u0926\u0928 3-7 \u0935\u0930\u094d\u0937 \u0915\u0940 \u0906\u092f\u0941 \u0915\u0947 \u091a\u0932-\u092b\u093f\u0930 \u0938\u0915\u0928\u0947 \u0935\u093e\u0932\u0947 \u0930\u094b\u0917\u093f\u092f\u094b\u0902 \u0915\u0947 \u0932\u093f\u090f \u0925\u093e\u0964 \u092a\u0930\u0940\u0915\u094d\u0937\u0923 \u0915\u0940 \u0930\u0942\u092a\u0930\u0947\u0916\u093e \u0914\u0930 \u092a\u094d\u0930\u093e\u0925\u092e\u093f\u0915 \u0938\u092e\u093e\u092a\u0928 \u092c\u093f\u0902\u0926\u0941 (NSAA \u092e\u0947\u0902 12 \u092e\u0939\u0940\u0928\u0947 \u0915\u093e \u092a\u0930\u093f\u0935\u0930\u094d\u0924\u0928) \u0915\u0947 \u091a\u092f\u0928 \u0915\u094b EMA \u0926\u094d\u0935\u093e\u0930\u093e \u0909\u0938 \u0938\u092e\u0942\u0939 \u092e\u0947\u0902 \u0930\u094b\u0917 \u0915\u0940 \u092a\u094d\u0930\u0917\u0924\u093f \u092e\u0947\u0902 \u0938\u093e\u0930\u094d\u0925\u0915 \u0915\u092e\u0940 \u092a\u094d\u0930\u0926\u0930\u094d\u0936\u093f\u0924 \u0915\u0930\u0928\u0947 \u0915\u0947 \u0932\u093f\u090f \u0905\u092a\u0930\u094d\u092f\u093e\u092a\u094d\u0924 \u092a\u093e\u092f\u093e \u0917\u092f\u093e\u0964<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>\u0907\u0938 \u0925\u0947\u0930\u0947\u092a\u0940 \u0915\u094b \u0915\u0941\u091b \u0905\u0928\u094d\u092f \u0915\u094d\u0937\u0947\u0924\u094d\u0930\u094b\u0902 (\u091c\u0948\u0938\u0947, \u091c\u093e\u092a\u093e\u0928 \u0914\u0930 \u0915\u0941\u091b \u092e\u0927\u094d\u092f \u092a\u0942\u0930\u094d\u0935 \u0926\u0947\u0936\u094b\u0902) \u092e\u0947\u0902 \u0935\u093f\u092d\u093f\u0928\u094d\u0928 \u0928\u093f\u092f\u093e\u092e\u0915 \u0922\u093e\u0901\u091a\u094b\u0902 \u0915\u0947 \u0924\u0939\u0924 \u0905\u0928\u0941\u092e\u094b\u0926\u093f\u0924 \u0915\u093f\u092f\u093e \u0917\u092f\u093e \u0925\u093e\u0964<a href=\"https:\/\/dmdwarrior.com\/hi\/in-which-countries-is-elevidys-approved-is-elevidys-approved-\/\" target=\"_blank\" rel=\"noreferrer noopener\">dmdwarrior.com<\/a>)<\/li>\n\n\n\n<li>EMA \u0915\u0940 \u0930\u093e\u092f (\u092e\u093e\u0928\u0935 \u0909\u092a\u092f\u094b\u0917 \u0915\u0947 \u0932\u093f\u090f \u0914\u0937\u0927\u0940\u092f \u0909\u0924\u094d\u092a\u093e\u0926\u094b\u0902 \u0915\u0940 \u0938\u092e\u093f\u0924\u093f, CHMP \u0915\u0947 \u092e\u093e\u0927\u094d\u092f\u092e \u0938\u0947) \u092f\u0942\u0930\u094b\u092a\u0940\u092f \u0906\u092f\u094b\u0917 \u0915\u0947 \u0928\u093f\u0930\u094d\u0923\u092f \u0924\u0915 \u0915\u093e\u0928\u0942\u0928\u0940 \u0930\u0942\u092a \u0938\u0947 \u092c\u093e\u0927\u094d\u092f\u0915\u093e\u0930\u0940 \u0928\u0939\u0940\u0902 \u0939\u0948, \u0932\u0947\u0915\u093f\u0928 \u0935\u094d\u092f\u0935\u0939\u093e\u0930 \u092e\u0947\u0902 CHMP \u0915\u0940 \u0928\u0915\u093e\u0930\u093e\u0924\u094d\u092e\u0915 \u0930\u093e\u092f \u0932\u0917\u092d\u0917 \u0939\u092e\u0947\u0936\u093e \u0907\u0928\u0915\u093e\u0930 \u0915\u093e \u0915\u093e\u0930\u0923 \u092c\u0928\u0924\u0940 \u0939\u0948\u0964<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\">\u0917\u094d\u0932\u094b\u092c\u0928\u094d\u092f\u0942\u091c\u0935\u093e\u092f\u0930<\/a>)<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"summary\">\u0938\u093e\u0930\u093e\u0902\u0936<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u092f\u0926\u094d\u092f\u092a\u093f Elevidys \u0921\u0940\u090f\u092e\u0921\u0940 \u0915\u0947 \u0932\u093f\u090f \u090f\u0915 \u0928\u0935\u0940\u0928 \u091c\u0940\u0928 \u0925\u0947\u0930\u0947\u092a\u0940 \u0926\u0943\u0937\u094d\u091f\u093f\u0915\u094b\u0923 \u092a\u094d\u0930\u0938\u094d\u0924\u0941\u0924 \u0915\u0930\u0924\u093e \u0939\u0948, EMA \u0928\u0947 \u0928\u093f\u0937\u094d\u0915\u0930\u094d\u0937 \u0928\u093f\u0915\u093e\u0932\u093e \u0915\u093f \u092a\u094d\u0930\u0938\u094d\u0924\u0941\u0924 \u0938\u093e\u0915\u094d\u0937\u094d\u092f \u092a\u0930\u094d\u092f\u093e\u092a\u094d\u0924 \u0930\u0942\u092a \u0938\u0947 \u092f\u0939 \u092a\u094d\u0930\u0926\u0930\u094d\u0936\u093f\u0924 \u0928\u0939\u0940\u0902 \u0915\u0930\u0924\u0947 \u0915\u093f \u092f\u0939 \u0932\u0915\u094d\u0937\u093f\u0924 \u091a\u0932\u0928\u0947-\u092b\u093f\u0930\u0928\u0947 \u092e\u0947\u0902 \u0938\u0915\u094d\u0937\u092e \u092c\u091a\u094d\u091a\u094b\u0902 (3-7 \u0935\u0930\u094d\u0937) \u092e\u0947\u0902 \u092e\u094b\u091f\u0930-\u0915\u093e\u0930\u094d\u092f \u092e\u0947\u0902 \u0938\u0941\u0927\u093e\u0930 \u0915\u0930\u0924\u093e \u0939\u0948 \u0914\u0930 \u0909\u0938 \u091c\u0928\u0938\u0902\u0916\u094d\u092f\u093e \u0915\u0947 \u0932\u093f\u090f \u0932\u093e\u092d-\u091c\u094b\u0916\u093f\u092e \u0905\u0928\u0941\u092a\u093e\u0924 \u0938\u094d\u0925\u093e\u092a\u093f\u0924 \u0928\u0939\u0940\u0902 \u0939\u0941\u0906 \u0925\u093e\u0964 \u0907\u0938\u0932\u093f\u090f \u0909\u0928\u094d\u0939\u094b\u0902\u0928\u0947 \u0935\u093f\u092a\u0923\u0928 \u092a\u094d\u0930\u093e\u0927\u093f\u0915\u0930\u0923 \u0915\u094b \u0905\u0938\u094d\u0935\u0940\u0915\u093e\u0930 \u0915\u0930\u0928\u0947 \u0915\u0940 \u0905\u0928\u0941\u0936\u0902\u0938\u093e \u0915\u0940\u0964<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/elevidys\" target=\"_blank\" rel=\"noreferrer noopener\">\u092f\u0942\u0930\u094b\u092a\u0940\u092f \u0914\u0937\u0927\u093f \u090f\u091c\u0947\u0902\u0938\u0940 (EMA)<\/a>)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u0914\u0930 \u092a\u0922\u093c\u0947\u0902<\/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\">\u0906\u092a \u0907\u0938 \u0932\u093f\u0902\u0915 \u0938\u0947 EMA \u0926\u094d\u0935\u093e\u0930\u093e \u092a\u094d\u0930\u0915\u093e\u0936\u093f\u0924 Elevidys \u0905\u0938\u094d\u0935\u0940\u0915\u0943\u0924\u093f \u0915\u0947 \u0915\u093e\u0930\u0923\u094b\u0902 \u092a\u0930 \u0935\u093f\u0938\u094d\u0924\u0943\u0924 \u0930\u093f\u092a\u094b\u0930\u094d\u091f \u0926\u0947\u0916 \u0938\u0915\u0924\u0947 \u0939\u0948\u0902\u0964.<\/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\/hi\/wp-json\/wp\/v2\/posts\/4826","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/comments?post=4826"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/posts\/4826\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/media\/4833"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/media?parent=4826"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/categories?post=4826"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/tags?post=4826"}],"curies":[{"name":"\u0921\u092c\u094d\u0932\u094d\u092f\u0942\u092a\u0940","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}