The Hague (AFP)
The European Medicines Agency (EMA) announced Monday that it has received a conditional marketing authorization application in the European Union for the antiviral remdesivir for the treatment of Covid-19 disease.
"The EMA has currently received a conditional marketing authorization (CMA) application for the antiviral drug remdesivir for the treatment of Covid-19 and has officially started its evaluation," the agency said in a statement.
The benefit and risk assessment of remdesivir will be carried out within a short period of time and an opinion could be issued "within a few weeks", depending on the strength of the data submitted and whether or not it is necessary to provide additional information to support the claim. assessment, she said.
In the United States, the Medicines Agency (FDA) authorized the emergency use of remdesivir in hospitals on May 1, followed by Japan, while Europe is considering a similar decision.
Originally developed in vain for Ebola haemorrhagic fever, remdesivir, developed by the American laboratory Gilead, is the first therapy to have demonstrated some efficacy in patients hospitalized for Covid-19 in a significant clinical trial, even if the The effect is considered modest.
The EMA has also recently announced the establishment of independent research in order to prepare for the surveillance of possible vaccines against the Covid-19 disease before and after their placing on the European market.
To authorize any vaccine against Covid-19, the EMA must have solid evidence from clinical trials on the safety, efficacy and quality of this vaccine, the agency said.
The EMA had estimated in mid-May that a vaccine against the new coronavirus could be ready within a year in an "optimistic" scenario.
© 2020 AFP