Earlier today, the European Commission granted 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.
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 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).
- 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the conditional MA (less than one month after Gilead’s MA application was made) and the MHRA’s Scientific Opinion was withdrawn.