EMA is aware that the World Health Organization (WHO) has updated its guidelines advising against the use of remdesivir in hospitalised patients with COVID-19, regardless of disease severity based on a recent meta-analysis.

Remdesivir was authorised in the EU in July 2020 as Veklury for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. Veklury was authorised on the basis of results from the NIAID-ACTT-1 trial, a randomised controlled trial involving 1,063 hospitalised patients with COVID-19 which showed an improvement in recovery time, reducing the time patients spent in hospital or on treatment. The data package was published on EMA's clinical data website.