Europe – Update on remdesivir – EMA will evaluate new data from Solidarity trial

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.

At the time of authorisation, EMA requested the company to submit additional data including data on mortality, in order to better characterise the effectiveness and safety of remdesivir. Day 28 mortality data from the NIAID study have also recently been made available and are under review by CHMP