EMA Requests Full Solidarity Trial Data to Evaluate Remdesivir Authorization

EMA has requested the full data from the Solidarity trial in order to evaluate the marketing authorization of Veklury (remdesivir) in the European Union.

According to a Nov. 20, 2020 press release, the European Medicines Agency (EMA) has requested the full data from the Solidarity trial in order to evaluate the marketing authorization of Veklury (remdesivir) in the European Union.

Veklury was authorized for use in the EU in July 2020 as a COVID-19 treatment for adults and adolescents of 12 years and older with pneumonia who require supplemental oxygen. The authorization was based on data from the NIAID-ACTT-1 trial, which included 1063 hospitalized patients with COVID-19. EMA also requested more data from the marketing authorization holder at the time of the product’s authorization.

The World Health Organization (WHO) has updated its guidelines, recommending that remdesivir is not used in hospitalized patients with COVID-19, based on a review and network meta-analysis of four randomized trials, including NIAID-ACTT-1 and the Solidarity trial. Additionally, WHO’s recommendation against the use of remdesivir, considers the cost of the therapy and the route of administration as implications on health resources.

EMA will assess the evidence, once the data has been made available, and will look at other data in its evaluation of the authorization of Veklury. The regulatory body has stated that it will provide further communication as necessary.

Source: EMA