{"id":13660,"date":"2023-09-20T01:03:00","date_gmt":"2023-09-19T17:03:00","guid":{"rendered":"https:\/\/flcube.com\/?p=13660"},"modified":"2024-11-20T01:05:58","modified_gmt":"2024-11-19T17:05:58","slug":"emas-chmp-supports-gileads-veklury-for-covid-19-patients-with-hepatic-impairment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=13660","title":{"rendered":"EMA’s CHMP Supports Gilead’s Veklury for COVID-19 Patients with Hepatic Impairment"},"content":{"rendered":"\n

The European Medicines Agency (EMA)\u2019s Committee for Medicinal Products for Human Use (CHMP) has recently endorsed the potential approval of Gilead\u2019s (NASDAQ: GILD<\/a>) repurposed antiviral Veklury (remdesivir) for the treatment of COVID-19 patients with mild-to-severe hepatic impairment. This milestone could position the nucleotide analog as the first COVID-19 treatment authorized for use across all stages of liver disease.<\/p>\n\n\n\n

Safety and Pharmacokinetics Review<\/strong>
The CHMP’s endorsement follows a review of safety and pharmacokinetics data from a Phase I study. The data suggests that no dose adjustment or liver function testing is necessary before or during treatment with Veklury, indicating its potential safety and efficacy in patients with hepatic impairment.<\/p>\n\n\n\n

Implications for COVID-19 Treatment<\/strong>
If approved, Veklury would provide a significant therapeutic option for COVID-19 patients with liver disease, who often face limited treatment options due to the potential for drug interactions and exacerbation of liver conditions. This endorsement by the CHMP highlights the importance of broadening access to effective COVID-19 treatments for all patient populations, including those with comorbidities.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

The European Medicines Agency (EMA)\u2019s Committee for Medicinal Products for Human Use (CHMP) has recently…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[13,226,1025,15],"class_list":["post-13660","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-covid-19","tag-gilead-sciences","tag-nasdaq-gild","tag-product-approvals"],"yoast_head":"\nEMA's CHMP Supports Gilead's Veklury for COVID-19 Patients with Hepatic Impairment - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The European Medicines Agency (EMA)\u2019s Committee for Medicinal Products for Human Use (CHMP) has recently endorsed the potential approval of Gilead\u2019s (NASDAQ: GILD) repurposed antiviral Veklury (remdesivir) for the treatment of COVID-19 patients with mild-to-severe hepatic impairment. This milestone could position the nucleotide analog as the first COVID-19 treatment authorized for use across all stages of liver 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:\/\/flcube.com\/?p=13660\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EMA's CHMP Supports Gilead's Veklury for COVID-19 Patients with Hepatic Impairment\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=13660\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China's Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2023-09-19T17:03:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-19T17:05:58+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1894\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Fineline Cube\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=13660#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=13660\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"EMA’s CHMP Supports Gilead’s Veklury for COVID-19 Patients with Hepatic Impairment\",\"datePublished\":\"2023-09-19T17:03:00+00:00\",\"dateModified\":\"2024-11-19T17:05:58+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=13660\"},\"wordCount\":188,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"COVID-19\",\"Gilead Sciences\",\"NASDAQ: GILD\",\"Product approvals\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=13660#respond\"]}],\"copyrightYear\":\"2023\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=13660\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=13660\",\"name\":\"EMA's CHMP Supports Gilead's Veklury for COVID-19 Patients with Hepatic Impairment - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2023-09-19T17:03:00+00:00\",\"dateModified\":\"2024-11-19T17:05:58+00:00\",\"description\":\"The European Medicines Agency (EMA)\u2019s Committee for Medicinal Products for Human Use (CHMP) has recently endorsed the potential approval of Gilead\u2019s (NASDAQ: GILD) repurposed antiviral Veklury (remdesivir) for the treatment of COVID-19 patients with mild-to-severe hepatic impairment. This milestone could position the nucleotide analog as the first COVID-19 treatment authorized for use across all stages of liver disease.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=13660#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=13660\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=13660#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"EMA’s CHMP Supports Gilead’s Veklury for COVID-19 Patients with Hepatic Impairment\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\",\"url\":\"https:\\\/\\\/flcube.com\\\/\",\"name\":\"Insight, China's Pharmaceutical Industry\",\"description\":\"Fineline Insights, Pharma Clarity\",\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/flcube.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\",\"name\":\"Fineline Infomation and Technology\",\"alternateName\":\"Fineline Info & Tech\",\"url\":\"https:\\\/\\\/flcube.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/Fineline-info-tech-scaled.jpg\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/Fineline-info-tech-scaled.jpg\",\"width\":2560,\"height\":1894,\"caption\":\"Fineline Infomation and Technology\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/profile.php?id=61566606313834\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\",\"name\":\"Fineline Cube\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"caption\":\"Fineline Cube\"},\"sameAs\":[\"https:\\\/\\\/flcube.com\"],\"url\":\"https:\\\/\\\/flcube.com\\\/?author=1\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"EMA's CHMP Supports Gilead's Veklury for COVID-19 Patients with Hepatic Impairment - Insight, China's Pharmaceutical Industry","description":"The European Medicines Agency (EMA)\u2019s Committee for Medicinal Products for Human Use (CHMP) has recently endorsed the potential approval of Gilead\u2019s (NASDAQ: GILD) repurposed antiviral Veklury (remdesivir) for the treatment of COVID-19 patients with mild-to-severe hepatic impairment. This milestone could position the nucleotide analog as the first COVID-19 treatment authorized for use across all stages of liver 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:\/\/flcube.com\/?p=13660","og_locale":"en_US","og_type":"article","og_title":"EMA's CHMP Supports Gilead's Veklury for COVID-19 Patients with Hepatic Impairment","og_description":"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM","og_url":"https:\/\/flcube.com\/?p=13660","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2023-09-19T17:03:00+00:00","article_modified_time":"2024-11-19T17:05:58+00:00","og_image":[{"width":2560,"height":1894,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","type":"image\/jpeg"}],"author":"Fineline Cube","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Fineline Cube","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=13660#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=13660"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"EMA’s CHMP Supports Gilead’s Veklury for COVID-19 Patients with Hepatic Impairment","datePublished":"2023-09-19T17:03:00+00:00","dateModified":"2024-11-19T17:05:58+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=13660"},"wordCount":188,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["COVID-19","Gilead Sciences","NASDAQ: GILD","Product approvals"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=13660#respond"]}],"copyrightYear":"2023","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=13660","url":"https:\/\/flcube.com\/?p=13660","name":"EMA's CHMP Supports Gilead's Veklury for COVID-19 Patients with Hepatic Impairment - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2023-09-19T17:03:00+00:00","dateModified":"2024-11-19T17:05:58+00:00","description":"The European Medicines Agency (EMA)\u2019s Committee for Medicinal Products for Human Use (CHMP) has recently endorsed the potential approval of Gilead\u2019s (NASDAQ: GILD) repurposed antiviral Veklury (remdesivir) for the treatment of COVID-19 patients with mild-to-severe hepatic impairment. This milestone could position the nucleotide analog as the first COVID-19 treatment authorized for use across all stages of liver disease.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=13660#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=13660"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=13660#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"EMA’s CHMP Supports Gilead’s Veklury for COVID-19 Patients with Hepatic Impairment"}]},{"@type":"WebSite","@id":"https:\/\/flcube.com\/#website","url":"https:\/\/flcube.com\/","name":"Insight, China's Pharmaceutical Industry","description":"Fineline Insights, Pharma Clarity","publisher":{"@id":"https:\/\/flcube.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/flcube.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/flcube.com\/#organization","name":"Fineline Infomation and Technology","alternateName":"Fineline Info & Tech","url":"https:\/\/flcube.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/","url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","width":2560,"height":1894,"caption":"Fineline Infomation and Technology"},"image":{"@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/profile.php?id=61566606313834"]},{"@type":"Person","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a","name":"Fineline Cube","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","caption":"Fineline Cube"},"sameAs":["https:\/\/flcube.com"],"url":"https:\/\/flcube.com\/?author=1"}]}},"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/13660","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=13660"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/13660\/revisions"}],"predecessor-version":[{"id":13661,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/13660\/revisions\/13661"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=13660"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=13660"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=13660"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}