Use of Remdesivir for treatment of COVID-19 patients

Author (Corporate)
Publication Date 2020
Content Type

Summary:

Reports and information relating to the use of the antiviral medication Remdesivir for treatment of patients diagnosed with COVID-19 (coronavirus).

Further information:

This medication is sold under the brand name Veklury. It is developed by bio-pharmaceutical company Gilead Sciences.

As the COVID-19 (coronavirus) pandemic unfolded, this medication was increasingly seen as a valid treatment for patients. Research was conducted to understand the effects on tackling this virus, following effective treatment against previous respiratory syndromes.

On 30 April 2020, the European Medicines Agency (EMA) started a rolling review of data on the use of Remdesivir in COVID‑19. The application for the marketing authorisation was submitted to the EMA on 5 June. EMA’s human medicines committee (CHMP) recommended on 25 June granting a conditional marketing authorisation to Veklury for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen.

On 3 July, this medication became the first treatment to be given a conditional marketing authorisation. The authorisation was provided just days after the company allocated nearly all of its supply of Remdesivir to the United States over a period of 3 months, raising concerns about availability elsewhere. This medication had already been made available on the United Kingdom's NHS in late May.

The European Commission signed an agreement with Gilead Sciences on 28 July to secure treatment doses of Veklury. The deal aimed to ensure the treatment of approximately 30,000 patients and help to cover the existing needs over the following few months. The Commission's Emergency Support Instrument was used to finance the contract.

Related Links
Official
EU EMA: Press Release, 03/04/2020: EMA provides recommendations on compassionate use of remdesivir for COVID-19 https://www.ema.europa.eu/en/news/ema-provides-recommendations-compassionate-use-remdesivir-covid-19
US NIAID: News Release, 29/04/2020: NIH Clinical Trial Shows Remdesivir Accelerates Recovery from Advanced COVID-19 https://www.niaid.nih.gov/news-events/nih-clinical-trial-shows-remdesivir-accelerates-recovery-advanced-covid-19
EU EMA: Press Release, 30/04/2020: EMA starts rolling review of remdesivir for COVID-19 https://www.ema.europa.eu/en/news/ema-starts-rolling-review-remdesivir-covid-19
EU EMA: Press Release, 25/06/2020: First COVID-19 treatment recommended for EU authorisation https://www.ema.europa.eu/en/news/first-covid-19-treatment-recommended-eu-authorisation
US FDA: News, 25/06/2020: Partnering with the European Union and Global Regulators on COVID-19 https://www.fda.gov/news-events/fda-voices/partnering-european-union-and-global-regulators-covid-19
Gilead Sciences: Press Release, 03/07/2020: European Commission Grants Conditional Marketing Authorization for Gilead’s Veklury® (remdesivir) for the Treatment of COVID-19 https://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
European Commission: Press Release, 29/07/2020: European Commission secures EU access to Remdesivir for treatment of COVID-19 https://ec.europa.eu/commission/presscorner/detail/en/ip_20_1416

News
The New York Times, 23/03/2020: Coronavirus Patients in Limbo as Gilead Suspends Emergency Drug Access https://www.nytimes.com/2020/03/23/health/coronavirus-drugs-remdesivir.html
BBC News, 23/04/2020: Hopes dashed as coronavirus drug remdesivir 'fails first trial' https://www.bbc.co.uk/news/world-52406261
Politico, 30/04/2020: EU drugs agency evaluates potential coronavirus treatment https://www.politico.eu/article/ema-begins-begins-evaluation-of-potential-coronavirus-treatment-remdesivir/
BBC News, 26/05/2020: Coronavirus: UK authorises anti-viral drug remdesivir https://www.bbc.co.uk/news/health-52805828
Euronews, 25/06/2020: Remdesivir becomes first COVID-19 drug put forward for use in the EU https://www.euronews.com/2020/06/25/remdesivir-becomes-first-covid-19-drug-put-forward-for-use-in-the-eu
British Medical Journal: News, 29/06/2020: Covid-19: Remdesivir is recommended for authorisation by European Medicines Agency https://www.bmj.com/content/369/bmj.m2610
Politico, 30/04/2020: EU drugs agency evaluates potential coronavirus treatment https://www.politico.com/news/2020/04/30/eu-drugs-agency-evaluates-potential-coronavirus-treatment-226993
The Wall Street Journal, 05/05/2020: Gilead Seeks Deals With Other Drugmakers to Boost Supply of Covid-19 Drug https://www.wsj.com/articles/gilead-seeks-deals-with-other-drugmakers-to-boost-supply-of-covid-19-drug-11588722931
Politico, 25/06/2020: EU agency backs first COVID-19 treatment https://www.politico.eu/article/remdesivir-is-first-covid-19-treatment-to-get-ema-recommendation/
Reuters, 25/06/2020: Gilead's remdesivir set to become Europe's first COVID-19 therapy https://www.reuters.com/article/idUSKBN23W1ZH
The Guardian, 30/06/2020: US secures world stock of key Covid-19 drug remdesivir https://www.theguardian.com/us-news/2020/jun/30/us-buys-up-world-stock-of-key-covid-19-drug
TIME, 01/07/2020: European Health Experts Concerned by U.S. Hoarding of Only Licensed Coronavirus Drug https://time.com/5862295/trump-buys-remdesivir-coronavirus-gilead/
TRT World, 01/07/2020: Germany says remdesivir supplies sufficient to treat Covid-19 patients https://www.trtworld.com/europe/germany-says-remdesivir-supplies-sufficient-to-treat-covid-19-patients-37774
Bloomberg, 01/07/2020: European Union in Talks With Gilead to Secure Covid Drug Supply https://www.bloomberg.com/news/articles/2020-07-01/europe-says-it-has-plenty-of-gilead-covid-drug-after-u-s-deal
EUObserver, 02/07/2020: EU silent on US buying up world's remdesivir supplies https://euobserver.com/coronavirus/148830
The Independent (UK), 02/07/2020: Remdesivir: EU in talks to secure doses of coronavirus drug after US bought up global supply https://www.independent.co.uk/news/world/europe/remdesivir-eu-gilead-coronavirus-drug-a9597531.html
Deutsche Welle, 03/07/2020: Coronavirus: EU approves COVID-19 drug remdesivir https://p.dw.com/p/3eiqz
Reuters, 03/07/2020: Gilead's COVID-19 antiviral remdesivir gets conditional EU clearance https://www.reuters.com/article/idUSKBN2441GK
Labiotech.eu, 08/07/2020: Remdesivir Becomes the First Covid-19 Treatment Approved in Europe https://www.labiotech.eu/medical/covid-19-remdesivir-europe/
France24, 09/07/2020: Covid-19 drug buyout: US's EU representative denies 'America First' policy on Remdesivir https://www.france24.com/en/europe/20200709-covid-19-drug-buyout-us-s-eu-representative-denies-america-first-policy-on-remdesivir
The Irish Times, 29/07/2020: Coronavirus: European Union signs Remdesivir deal with Gilead https://www.irishtimes.com/business/health-pharma/coronavirus-european-union-signs-remdesivir-deal-with-gilead-1.4316563
Reuters, 29/07/2020: EU buys remdesivir to treat 30,000 COVID patients, seeks more https://uk.reuters.com/article/idUKKCN24U1J2
Bloomberg, 29/07/2020: EU, Gilead Reach Deal on Supply of Antiviral Drug Remdesivir https://www.bloomberg.com/news/articles/2020-07-29/eu-gilead-reach-deal-on-supply-of-antiviral-drug-remdesivir
RTÉ News, 29/07/2020: EU buys enough remdesivir to treat 30,000 Covid cases, seeks more https://www.rte.ie/news/2020/0729/1156131-covid-19-vaccine/
Politico, 29/07/2020: Commission inks deal for COVID-19 treatment remdesivir https://www.politico.eu/article/commission-inks-deal-for-covid-19-treatment-remdesivir/
EUObserver, 30/07/2020: EU secures remdesivir supplies for 30,000 patients https://euobserver.com/coronavirus/149064

Commentary and Analysis
Wikipedia: Remdesivir https://en.wikipedia.org/wiki/Remdesivir
Forbes, 10/03/2020: Buy Gilead...But Not Because Of Remdesivir https://www.forbes.com/sites/jamesberman/2020/03/10/buy-gileadbut-not-because-of-remdesivir/#4441154120d5
Euronews, 25/06/2020: What is Remdesivir, the first drug put forward to treat COVID-19 in Europe? https://www.euronews.com/2020/06/25/what-is-remdesivir-the-first-drug-put-forward-to-treat-covid-19-in-europe
The Conversation, 03/07/2020: The US has bought most of the world’s remdesivir. Here’s what it means for the rest of us https://theconversation.com/the-us-has-bought-most-of-the-worlds-remdesivir-heres-what-it-means-for-the-rest-of-us-141791
Deutsche Welle, 09/07/2020: Is compulsory licensing of remdesivir a feasible option? https://p.dw.com/p/3f0jY

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