{"id":4222,"date":"2025-07-25T14:46:11","date_gmt":"2025-07-25T11:46:11","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=4222"},"modified":"2025-10-21T14:29:47","modified_gmt":"2025-10-21T11:29:47","slug":"the-european-medicines-agency-ema-issued-a-negative-opinion-on-elevidys","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/hi\/the-european-medicines-agency-ema-issued-a-negative-opinion-on-elevidys\/","title":{"rendered":"\u092f\u0942\u0930\u094b\u092a\u0940\u092f \u091a\u093f\u0915\u093f\u0924\u094d\u0938\u093e \u090f\u091c\u0947\u0902\u0938\u0940 (EMA) \u0928\u0947 Elevidys \u092a\u0930 \u0928\u0915\u093e\u0930\u093e\u0924\u094d\u092e\u0915 \u0930\u093e\u092f \u091c\u093e\u0930\u0940 \u0915\u0940"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u0930\u094b\u0936 \u0928\u0947 \u0906\u091c \u0918\u094b\u0937\u0923\u093e \u0915\u0940 \u0915\u093f \u092f\u0942\u0930\u094b\u092a\u0940\u092f \u092e\u0947\u0921\u093f\u0938\u093f\u0928 \u090f\u091c\u0947\u0902\u0938\u0940 (EMA) \u0915\u0940 \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) \u0928\u0947 \u0921\u094d\u092f\u0942\u0936\u0947\u0928 \u092e\u0938\u094d\u0915\u0941\u0932\u0930 \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u0949\u092b\u0940 (DMD) \u0938\u0947 \u092a\u0940\u0921\u093c\u093f\u0924 \u0924\u0940\u0928 \u0938\u0947 \u0938\u093e\u0924 \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 \u0935\u094d\u092f\u0915\u094d\u0924\u093f\u092f\u094b\u0902 \u0915\u0947 \u0932\u093f\u090f Elevidys (\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) \u0915\u0947 \u0938\u0936\u0930\u094d\u0924 \u0935\u093f\u092a\u0923\u0928 \u092a\u094d\u0930\u093e\u0927\u093f\u0915\u0930\u0923 (CMA) \u092a\u0930 \u0928\u0915\u093e\u0930\u093e\u0924\u094d\u092e\u0915 \u0930\u093e\u092f \u091c\u093e\u0930\u0940 \u0915\u0940 \u0939\u0948\u0964 <a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/elevidys\" target=\"_blank\" rel=\"noreferrer noopener\">\u0914\u0930 \u092a\u0922\u093c\u0947\u0902<\/a> \u2013 <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0921\u0940\u090f\u092e\u0921\u0940 \u092e\u0947\u0902 \u0909\u091a\u094d\u091a \u0905\u092a\u0942\u0930\u094d\u0923 \u0906\u0935\u0936\u094d\u092f\u0915\u0924\u093e \u0915\u094b \u0926\u0947\u0916\u0924\u0947 \u0939\u0941\u090f, \u0930\u094b\u0936 \u0928\u0947 \u0906\u0917\u0947 \u0915\u0940 \u0938\u0902\u092d\u093e\u0935\u093f\u0924 \u0930\u093e\u0939 \u0924\u0932\u093e\u0936\u0928\u0947 \u0915\u0947 \u0932\u093f\u090f 1\u091f\u0940\u092a\u0940114\u091f\u0940 \u0915\u0947 \u0938\u093e\u0925 \u0915\u093e\u092e \u0915\u0930\u0928\u093e \u091c\u093e\u0930\u0940 \u0930\u0916\u0928\u0947 \u0915\u0940 \u092f\u094b\u091c\u0928\u093e \u092c\u0928\u093e\u0908 \u0939\u0948\u0964<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Elevidys \u0915\u094b \u092f\u0942\u0930\u094b\u092a\u0940\u092f \u0914\u0937\u0927\u093f \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?<\/strong><\/h2>\n\n\n\n<h4 class=\"wp-block-heading\">\u0907\u0928\u0915\u093e\u0930 \u0915\u0947 \u092a\u094d\u0930\u092e\u0941\u0916 \u0915\u093e\u0930\u0923<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">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:<\/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 \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.<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\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.<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\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\u0928\u0947 \u092a\u0930 \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.<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\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 \u0915\u093e \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 \u092d\u0940 \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, \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 \u0917\u092f\u093e\u0964.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u0914\u0930 \u0905\u0927\u093f\u0915 \u091c\u093e\u0928\u0947\u0902:&nbsp;<a href=\"https:\/\/dmdwarrior.com\/hi\/roche-suspends-shipments-of-elevidys-gene-therapy-outside-of-the-united-states\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u0930\u094b\u0936 \u0928\u0947 \u0938\u0902\u092f\u0941\u0915\u094d\u0924 \u0930\u093e\u091c\u094d\u092f \u0905\u092e\u0947\u0930\u093f\u0915\u093e \u0915\u0947 \u092c\u093e\u0939\u0930 Elevidys \u091c\u0940\u0928 \u0925\u0947\u0930\u0947\u092a\u0940 \u0915\u0940 \u0936\u093f\u092a\u092e\u0947\u0902\u091f \u0928\u093f\u0932\u0902\u092c\u093f\u0924 \u0915\u0930 \u0926\u0940<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Roche announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion on the conditional marketing authorisation (CMA) for Elevidys (delandistrogene moxeparvovec) for ambulatory individuals aged three to seven years with Duchenne muscular dystrophy (DMD). &#8211; Read More &#8211; Given the high unmet need [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":4226,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[121,33,179,91,213],"class_list":["post-4222","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-delandistrogene-moxeparvovec","tag-elevidys","tag-elevidys-gene-therapy","tag-ema","tag-european-medicines-agency"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/posts\/4222","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=4222"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/posts\/4222\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/media\/4226"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/media?parent=4222"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/categories?post=4222"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/tags?post=4222"}],"curies":[{"name":"\u0921\u092c\u094d\u0932\u094d\u092f\u0942\u092a\u0940","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}