{"id":47779,"date":"2020-06-26T03:00:07","date_gmt":"2020-06-26T01:00:07","guid":{"rendered":"https:\/\/www.cde.ual.es\/?p=47779"},"modified":"2020-06-25T20:42:17","modified_gmt":"2020-06-25T18:42:17","slug":"first-covid-19-treatment-recommended-for-eu-authorization","status":"publish","type":"post","link":"https:\/\/www.cde.ual.es\/en\/first-covid-19-treatment-recommended-for-eu-authorization\/","title":{"rendered":"First COVID-19 treatment recommended for EU authorization"},"content":{"rendered":"<p><strong>EMA\u2019s human medicines committee (<a id=\"glossary-term-43090\" class=\"ecl-link glossary-term\" title=\"Committee for Medicinal Products for Human Use - the committee that is responsible for preparing the Agency's opinions on questions concerning human medicines.\u00a0 More information can be found under 'Committee for Medicinal Products for Human Use (CHMP)'.\" href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/chmp\" target=\"_blank\" rel=\"noopener noreferrer\">CHMP<\/a>) has recommended granting <a id=\"glossary-term-43109\" class=\"ecl-link glossary-term\" title=\"The approval of a medicine that address unmet medical needs of patients on the basis of less comprehensive data than normally required. The available data must indicate that the medicine\u2019s benefits outweigh its risks and the applicant should be in a position to provide the comprehensive clinical data in the future.\u00a0 More information can be found under 'Conditional marketing authorisation'.\" href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/conditional-marketing-authorisation\" target=\"_blank\" rel=\"noopener noreferrer\">conditional marketing authorisation<\/a> to Veklury (remdesivir) for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen<\/strong><\/p>\n<p><a href=\"https:\/\/www.cde.ual.es\/wp-content\/uploads\/2020\/06\/covid-19_remdisivir.jpg\"><img decoding=\"async\" class=\"alignnone size-medium wp-image-47777\" src=\"https:\/\/www.cde.ual.es\/wp-content\/uploads\/2020\/06\/covid-19_remdisivir-300x225.jpg\" alt=\"\" width=\"300\" height=\"225\" srcset=\"https:\/\/www.cde.ual.es\/wp-content\/uploads\/2020\/06\/covid-19_remdisivir-300x225.jpg 300w, https:\/\/www.cde.ual.es\/wp-content\/uploads\/2020\/06\/covid-19_remdisivir.jpg 640w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/a><\/p>\n<p>Remdesivir is the first medicine against COVID-19 to be recommended for authorisation in the EU. Data on remdesivir were assessed in an exceptionally short timeframe through a <a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-starts-rolling-review-remdesivir-covid-19\">rolling review<\/a> procedure, an approach used by EMA during public health emergencies to assess data as they become available. From 30 April 2020, the <a id=\"glossary-term-43090\" class=\"ecl-link glossary-term\" title=\"Committee for Medicinal Products for Human Use - the committee that is responsible for preparing the Agency's opinions on questions concerning human medicines.\u00a0 More information can be found under 'Committee for Medicinal Products for Human Use (CHMP)'.\" href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/chmp\" target=\"_blank\" rel=\"noopener noreferrer\">CHMP<\/a> began assessing data on quality and manufacturing, non-clinical data, preliminary clinical data and supporting safety data from <a id=\"glossary-term-43105\" class=\"ecl-link glossary-term\" title=\"The use of an unauthorised medicine outside a clinical study in individual patients under strictly controlled conditions. This helps to make medicines that are still under development available to patients.\u00a0 More information can be found under 'Compassionate use'\" href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/compassionate-use\" target=\"_blank\" rel=\"noopener noreferrer\">compassionate use<\/a> programmes, well in advance of the submission of the <a id=\"glossary-term-43238\" class=\"ecl-link glossary-term\" title=\"An application made to a European regulatory authority for approval to market a medicine within the European Union.\" href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/marketing-authorisation-application\" target=\"_blank\" rel=\"noopener noreferrer\">marketing authorisation application<\/a> on 5 June<\/p>\n<p>The assessment of the dossier has now concluded with today\u2019s recommendation, which is mainly based on data from study NIAID-ACTT-1, sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID), plus supporting data from other studies on remdesivir<\/p>\n<p>Taking into consideration the available data, the Agency considered that the balance of benefits and risks had been shown to be positive in patients with pneumonia requiring supplemental oxygen; i.e., the patients with severe disease. Remdesivir is given by infusion (drip) into a vein and its use is limited to healthcare facilities in which patients can be monitored closely; liver and kidney function should be monitored before and during treatment, as appropriate. Treatment should start with a 200-mg infusion on the first day, followed by one 100-mg infusion a day for at least 4 days and no more than 9 days<\/p>\n<p>&nbsp;<\/p>\n<h3>More information:<\/h3>\n<p><a href=\"https:\/\/www.ema.europa.eu\/en\/news\/first-covid-19-treatment-recommended-eu-authorisation\">European Medicine Agency news<\/a><\/p>\n<p><a class=\"ecl-link--external\" href=\"https:\/\/www.niaid.nih.gov\/news-events\/nih-clinical-trial-shows-remdesivir-accelerates-recovery-advanced-covid-19\" target=\"_blank\" rel=\"noopener noreferrer\">NIH Clinical Trial Shows Remdesivir Accelerates Recovery from Advanced COVID-19<\/a><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>EMA\u2019s human medicines committee (CHMP) has recommended granting conditional marketing authorisation to Veklury (remdesivir) for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen Remdesivir is the first medicine against COVID-19 to be recommended for authorisation in the EU. Data on remdesivir were assessed in [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":47777,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":""},"categories":[4093,346,4094,4092],"tags":[2019,1352,2366,760,2018,2020],"class_list":{"0":"post-47779","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-diseases","8":"category-eu-news","9":"category-farmac","10":"category-health","11":"tag-chmp-en","12":"tag-covid-19","13":"tag-covid-19-2-en","14":"tag-medicine","15":"tag-niaid","16":"tag-remdesivir-en","17":"entry"},"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>First COVID-19 treatment recommended for EU authorization | CDE Almer\u00eda - Centro de Documentaci\u00f3n Europea - Universidad de Almer\u00eda<\/title>\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.cde.ual.es\/en\/first-covid-19-treatment-recommended-for-eu-authorization\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"First COVID-19 treatment recommended for EU authorization | CDE Almer\u00eda - Centro de Documentaci\u00f3n Europea - Universidad de Almer\u00eda\" \/>\n<meta property=\"og:description\" content=\"EMA\u2019s human medicines committee (CHMP) has recommended granting conditional marketing authorisation to Veklury (remdesivir) for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen Remdesivir is the first medicine against COVID-19 to be recommended for authorisation in the EU. 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