{"id":38070,"date":"2020-06-01T07:41:03","date_gmt":"2020-06-01T07:41:03","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=38070"},"modified":"2020-06-01T15:55:30","modified_gmt":"2020-06-01T15:55:30","slug":"ema-recommends-expanding-access-to-remdesivir","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/38070","title":{"rendered":"EMA recommends expanding access to remdesivir"},"content":{"rendered":"

EMA press release<\/span><\/strong><\/p>\n

EMA\u2019s\u00a0human medicines committee (CHMP)\u00a0has recommended expanding the\u00a0compassionate use\u00a0of the investigational medicine remdesivir so that more patients with severe COVID\u201119 can be treated.<\/span><\/strong><\/p>\n

In addition to patients undergoing invasive mechanical ventilation, the\u00a0compassionate use\u00a0recommendations now cover the treatment of hospitalised patients requiring supplemental oxygen, non-invasive ventilation, high-flow oxygen devices or ECMO (extracorporeal membrane oxygenation).<\/span><\/p>\n

The updated recommendations are based on preliminary results from the\u00a0NIAID-ACTT study, which suggest a beneficial effect of remdesivir in the treatment of hospitalised patients with severe COVID-19. EMA is currently evaluating these data in the context of the\u00a0rolling review of remdesivir.<\/span><\/p>\n

In addition, a treatment duration of 5 days has been introduced alongside the longer 10-day course, based on preliminary results from another study (GS-US-540-5773) suggesting that for patients not requiring mechanical ventilation or ECMO, the treatment course may be shortened from 10 to 5 days without any loss of\u00a0efficacy. Patients who receive a 5-day treatment course but do not show clinical improvement will be eligible to continue receiving remdesivir for an additional 5 days. The option to shorten treatment duration also means that more patients may be able to receive the medicine, which is in very high demand worldwide.<\/span><\/p>\n

Although remdesivir is not yet authorised for marketing in the European Union, these recommendations for\u00a0compassionate use\u00a0will help some patients with severe COVID-19 access the medicine while EMA evaluates data on its benefits and risks. When the evaluation is complete, EMA will make a recommendation on whether or not remdesivir should receive a\u00a0marketing authorisation.<\/span><\/p>\n

On 30 April 2020, the EMA also announced the start of a rolling review for data related to evaluating remdesivir in the EU, [2]<\/span><\/p>\n

comment<\/h3>\n

The UK MHRA have already approved access to remdesivir, although criteria exclude important people who could benefit.<\/strong><\/p>\n

Remdesivir should be considered the new standard of care in appropriate research studies.<\/strong><\/p>\n

References<\/span><\/p>\n

    \n
  1. EMA recommends expanding remdesivir compassionate use to patients not on mechanical ventilation (11 May 2020).
    \nhttps:\/\/www.ema.europa.eu\/en\/news\/ema-recommends-expanding-remdesivir-compassionate-use-patients-not-mechanical-ventilation<\/a><\/li>\n
  2. EMA starts rolling review of remdesivir for COVID-19. (30 April 2020).
    \n<\/span>    https:\/\/www.ema.europa.eu\/en\/news\/ema-starts-rolling-review-remdesivir-covid-19<\/span><\/a><\/li>\n<\/ol>\n

    \u00a0<\/span><\/p>\n

    \u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

    EMA press release EMA\u2019s\u00a0human medicines committee (CHMP)\u00a0has recommended expanding the\u00a0compassionate use\u00a0of the investigational medicine remdesivir so that more patients with severe COVID\u201119 can be treated. In addition to patients undergoing invasive mechanical ventilation, the\u00a0compassionate use\u00a0recommendations now cover the treatment of …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[286,278],"tags":[],"class_list":["post-38070","post","type-post","status-publish","format-standard","hentry","category-covid-19-treatment-access","category-covid-19"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/38070","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=38070"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/38070\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=38070"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=38070"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=38070"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}