On Jul. 3, 2020, 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 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the conditional MA (less than one month after Gilead’s MA application was made) and the MHRA’s Scientific Opinion was withdrawn.

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).