{"id":38348,"date":"2020-07-22T07:27:43","date_gmt":"2020-07-22T07:27:43","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=38348"},"modified":"2020-07-23T17:39:22","modified_gmt":"2020-07-23T17:39:22","slug":"ema-recommends-approval-for-remdesivir-in-the-eu-to-treat-covid-19","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/38348","title":{"rendered":"EMA grants conditional approval for remdesivir in the EU to treat COVID-19"},"content":{"rendered":"

Simon Collins, HIV i-Base<\/span><\/strong><\/p>\n

On 3 July 2020, the European Medicines Agency (EMA) announced conditional approval in the EU for remdesivir as a treatment for COVID-19. This was only a week after the CHMP had recommended approval. [1, 2]<\/span><\/strong><\/p>\n

Conditional approval will allow immediate access to remdesivir and is valid for one year, but also requires supplementary efficacy and safety results to be submitted by August and December 2020.\u00a0<\/span><\/p>\n

Although the submission for approval was only made on 5 June, the EMA has been evaluating accumulating results from remdesivir studies since late April.<\/span><\/p>\n

The indication is for adults and children (>12 years old and weighing >40 kg) with pneumonia who require supplemental oxygen.<\/span><\/p>\n

Approval is largely based on results from the US NIH randomised placebo-controlled ACTT study that reported an overall average 5-day shorter recovery time (approximately 9 vs 15 days) with remdesivir (dosed for 10 days) compared to placebo. [3]<\/span><\/p>\n

However, differences were reported depending on severity of COVID-19 at baseline. No differences were reported for participants with mild-moderate disease (at 5 days in both active and placebo arms) or in people who started mechanical ventilation while already taking remdesivir. The difference was driven by the 90% of participants with severe disease (12 vs 18 days).<\/span><\/p>\n

Remdesivir is manufactured by Gilead Sciences with the trade name Veklury. Other research studies are ongoing.<\/span><\/p>\n

The dose is not referred to in the press release (specifically whether this should be up to five or ten days).<\/span><\/p>\n

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

    \n
  1. Gilead press release. European Commission grants conditional marketing authorization for Gilead\u2019s Veklury (remdesivir) for the treatment of COVID-19. (3 July 2020).
    \nhttps:\/\/www.gilead.com\/news-and-press\/press-room\/press-releases\/2020\/7\/european-commission-grants-conditional-marketing-authorization-for-gileads-veklury-remdesivir-for-the-treatment-of-covid19<\/a><\/li>\n
  2. EMA press release. First COVID-19 treatment recommended for EU authorization. (25 June 2020).
    \n<\/span>    https:\/\/www.ema.europa.eu\/en\/news\/first-covid-19-treatment-recommended-eu-authorisation<\/a><\/li>\n
  3. Remdesivir improves recovery time in early COVID-19 infection: first definitive results of benefit. HTB (supple 4). (1 June 2020).
    \n    https:\/\/i-base.info\/htb\/37976<\/a><\/li>\n<\/ol>\n

    This report was first published on 2 July 2020.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base On 3 July 2020, the European Medicines Agency (EMA) announced conditional approval in the EU for remdesivir as a treatment for COVID-19. This was only a week after the CHMP had recommended approval. [1, 2] Conditional …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[283,278],"tags":[],"class_list":["post-38348","post","type-post","status-publish","format-standard","hentry","category-covid-19-investigational-drugs","category-covid-19"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/38348","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=38348"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/38348\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=38348"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=38348"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=38348"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}