{"id":1276,"date":"2016-09-23T16:53:06","date_gmt":"2016-09-23T11:23:06","guid":{"rendered":"https:\/\/delveinsightblog.wordpress.com\/?p=1276"},"modified":"2023-06-16T10:42:07","modified_gmt":"2023-06-16T05:12:07","slug":"the-snippet-fda-approves-sareptas-muscular-dystrophy-drug-after-months-of-debate","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/the-snippet-fda-approves-sareptas-muscular-dystrophy-drug-after-months-of-debate","title":{"rendered":"FDA Approves Sarepta\u2019s Muscular Dystrophy Drug after Months of Debate"},"content":{"rendered":"<p style=\"text-align: justify;\">The Food and Drug Administration approved the recent controversial drug to treat Duchenne muscular Dystrophy, which is a rare disease that confines boys to wheelchairs and condemns them to an early death. The decision was made after months of debate between the Agency and Sarepta Therapeutics, regarding the evidence needed to demonstrate that its medication, called eteplirsen, had a meaningful impact on patients. Sarepta said the drug would be priced at about $300,000 a year in the US. As a condition of the approval, Sarepta will have to conduct a two-year, randomized controlled trial to verify the clinical benefit of the drug. The purpose is to determine whether the drug actually improves motor functions. If the trial fails, the FDA could move to withdraw approval.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Food and Drug Administration approved the recent controversial drug to treat Duchenne muscular Dystrophy, which is a rare disease that confines boys to wheelchairs and condemns them to an early death. The decision was made after months of debate between the Agency and Sarepta Therapeutics, regarding the evidence needed to demonstrate that its medication, [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1279,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[41],"tags":[1796,704,502,2581],"industry":[17225],"therapeutic_areas":[17238,17241,17234],"class_list":["post-1276","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-snippets","tag-duchenne-muscular-dystrophy","tag-fda","tag-rare-disease","tag-sarepta-therapeutics","industry-pharmaceutical","therapeutic_areas-genetic-disorders","therapeutic_areas-musculoskeletal","therapeutic_areas-rare-diseases"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA approves Sarepta\u2019s Muscular Dystrophy Drug | Eteplirsen Updates<\/title>\n<meta name=\"description\" content=\"The Food and Drug Administration approved the recent controversial drug to treat Duchenne muscular Dystrophy, which is a rare disease\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.delveinsight.com\/blog\/the-snippet-fda-approves-sareptas-muscular-dystrophy-drug-after-months-of-debate\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA approves Sarepta\u2019s Muscular Dystrophy Drug | Eteplirsen Updates\" \/>\n<meta property=\"og:description\" content=\"The Food and Drug Administration approved the recent controversial drug to treat Duchenne muscular Dystrophy, which is a rare disease\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.delveinsight.com\/blog\/the-snippet-fda-approves-sareptas-muscular-dystrophy-drug-after-months-of-debate\" \/>\n<meta property=\"og:site_name\" content=\"DelveInsight Business Research\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/DelveInsight-1423323754607782\/\" \/>\n<meta property=\"article:published_time\" content=\"2016-09-23T11:23:06+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-06-16T05:12:07+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2016\/09\/09023052\/pharmaceutical-drugs-from-india-under-fda-scanner4-e1392583054230.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"620\" \/>\n\t<meta property=\"og:image:height\" content=\"356\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"DelveInsight\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@DelveInsight\" \/>\n<meta name=\"twitter:site\" content=\"@DelveInsight\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"DelveInsight\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"FDA approves Sarepta\u2019s Muscular Dystrophy Drug | Eteplirsen Updates","description":"The Food and Drug Administration approved the recent controversial drug to treat Duchenne muscular Dystrophy, which is a rare disease","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.delveinsight.com\/blog\/the-snippet-fda-approves-sareptas-muscular-dystrophy-drug-after-months-of-debate","og_locale":"en_US","og_type":"article","og_title":"FDA approves Sarepta\u2019s Muscular Dystrophy Drug | Eteplirsen Updates","og_description":"The Food and Drug Administration approved the recent controversial drug to treat Duchenne muscular Dystrophy, which is a rare disease","og_url":"https:\/\/www.delveinsight.com\/blog\/the-snippet-fda-approves-sareptas-muscular-dystrophy-drug-after-months-of-debate","og_site_name":"DelveInsight Business Research","article_publisher":"https:\/\/www.facebook.com\/DelveInsight-1423323754607782\/","article_published_time":"2016-09-23T11:23:06+00:00","article_modified_time":"2023-06-16T05:12:07+00:00","og_image":[{"width":620,"height":356,"url":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2016\/09\/09023052\/pharmaceutical-drugs-from-india-under-fda-scanner4-e1392583054230.jpg","type":"image\/jpeg"}],"author":"DelveInsight","twitter_card":"summary_large_image","twitter_creator":"@DelveInsight","twitter_site":"@DelveInsight","twitter_misc":{"Written by":"DelveInsight","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.delveinsight.com\/blog\/the-snippet-fda-approves-sareptas-muscular-dystrophy-drug-after-months-of-debate","url":"https:\/\/www.delveinsight.com\/blog\/the-snippet-fda-approves-sareptas-muscular-dystrophy-drug-after-months-of-debate","name":"FDA approves Sarepta\u2019s Muscular Dystrophy Drug | Eteplirsen Updates","isPartOf":{"@id":"https:\/\/www.delveinsight.com\/blog\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.delveinsight.com\/blog\/the-snippet-fda-approves-sareptas-muscular-dystrophy-drug-after-months-of-debate#primaryimage"},"image":{"@id":"https:\/\/www.delveinsight.com\/blog\/the-snippet-fda-approves-sareptas-muscular-dystrophy-drug-after-months-of-debate#primaryimage"},"thumbnailUrl":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2016\/09\/09023052\/pharmaceutical-drugs-from-india-under-fda-scanner4-e1392583054230.jpg","datePublished":"2016-09-23T11:23:06+00:00","dateModified":"2023-06-16T05:12:07+00:00","author":{"@id":"https:\/\/www.delveinsight.com\/blog\/#\/schema\/person\/5fbf6ca478835d03fdb5e17d905b520a"},"description":"The Food and Drug Administration approved the recent controversial drug to treat Duchenne muscular Dystrophy, which is a rare disease","inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.delveinsight.com\/blog\/the-snippet-fda-approves-sareptas-muscular-dystrophy-drug-after-months-of-debate"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.delveinsight.com\/blog\/the-snippet-fda-approves-sareptas-muscular-dystrophy-drug-after-months-of-debate#primaryimage","url":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2016\/09\/09023052\/pharmaceutical-drugs-from-india-under-fda-scanner4-e1392583054230.jpg","contentUrl":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2016\/09\/09023052\/pharmaceutical-drugs-from-india-under-fda-scanner4-e1392583054230.jpg","width":620,"height":356},{"@type":"WebSite","@id":"https:\/\/www.delveinsight.com\/blog\/#website","url":"https:\/\/www.delveinsight.com\/blog\/","name":"DelveInsight Business Research","description":"Blog","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.delveinsight.com\/blog\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/www.delveinsight.com\/blog\/#\/schema\/person\/5fbf6ca478835d03fdb5e17d905b520a","name":"DelveInsight","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.delveinsight.com\/blog\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/afdd550c64e18f6ad8957080b017c6ae55f4916951d641d3cd40264176aa0e86?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/afdd550c64e18f6ad8957080b017c6ae55f4916951d641d3cd40264176aa0e86?s=96&d=mm&r=g","caption":"DelveInsight"}}]}},"author_meta":{"display_name":"DelveInsight","author_link":"https:\/\/www.delveinsight.com\/blog\/author\/gtadmin"},"featured_img":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2016\/09\/09023052\/pharmaceutical-drugs-from-india-under-fda-scanner4-e1392583054230-300x172.jpg","coauthors":[],"tax_additional":{"categories":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/snippets\/\" class=\"advgb-post-tax-term\">Snippets - A Small piece of News or Article<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Snippets - A Small piece of News or Article<\/span>"]},"tags":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/snippets\/\" class=\"advgb-post-tax-term\">Duchenne muscular dystrophy<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/snippets\/\" class=\"advgb-post-tax-term\">FDA<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/snippets\/\" class=\"advgb-post-tax-term\">Rare Disease<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/snippets\/\" class=\"advgb-post-tax-term\">Sarepta Therapeutics<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Duchenne muscular dystrophy<\/span>","<span class=\"advgb-post-tax-term\">FDA<\/span>","<span class=\"advgb-post-tax-term\">Rare Disease<\/span>","<span class=\"advgb-post-tax-term\">Sarepta Therapeutics<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 10 years ago","modified":"Updated 3 years ago"},"absolute_dates":{"created":"Posted on Sep 23, 2016","modified":"Updated on Jun 16, 2023"},"absolute_dates_time":{"created":"Posted on Sep 23, 2016 4:53 pm","modified":"Updated on Jun 16, 2023 10:42 am"},"featured_img_caption":"","series_order":"","_links":{"self":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/1276","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/comments?post=1276"}],"version-history":[{"count":0,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/1276\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media\/1279"}],"wp:attachment":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media?parent=1276"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/categories?post=1276"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/tags?post=1276"},{"taxonomy":"industry","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/industry?post=1276"},{"taxonomy":"therapeutic_areas","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/therapeutic_areas?post=1276"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}