Gilead’s remdesivir granted conditional Marketing Authorisation by the European Commission

03.07.2020

Earlier today, the European Commission granted[1] a conditional Marketing Authorisation (MA) in respect of Gilead’s Veklury (remdesivir) for the treatment of COVID-19 in adults and adolescents with pneumonia requiring supplemental oxygen. This follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on 25 June 2020[2].

The centralised grant of the conditional MA supersedes authorisation at a national level and so has resulted in the withdrawal of the MHRA’s Scientific Opinion[3] in respect of the use of remdesivir to treat COVID-19 in adults and adolescents with a suspected or laboratory confirmed SARS-CoV-2 infection and severe disease.

Remdesivir is the first medicine authorised at EU level for the treatment of COVID-19 and the timescales involved in its authorisation reflect the highly dynamic nature of the response to this pandemic:

  • On 26 May 2020, the MHRA published a Scientific Opinion in respect of remdesivir under the Early Access to Medicines Scheme.
  • On 5 June 2020, Gilead submitted its MA application in respect of Veklury (remdesivir)[4].
  • On 25 June 2020, the CHMP issued a positive opinion in respect of a conditional MA in respect of Veklury (remdesivir).
  • On 3 July 2020, the European Commission granted the conditional MA (less than one month after Gilead’s MA application was made) and the MHRA’s Scientific Opinion was withdrawn.

 

[1] https://ec.europa.eu/health/documents/community-register/html/h1459.htm

[2] https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-veklury_en.pdf

[3] See here

[4] https://www.ema.europa.eu/en/news/first-covid-19-treatment-recommended-eu-authorisation

Alex Denoon

Author

Sam Harvey

Author