"The EMA's Committee for Human Medicinal Products (CHMP) has recommended the granting of a conditional marketing authorisation for the oral antiviral drug Paxlovid for the treatment of Covid-19," the European regulator said in a statement.

According to the European agency, this drug from the Pfizer pharmaceutical company is recommended at this stage for adults who do not need supplemental oxygen and who are at higher risk of developing a severe form of Covid-19.

According to the EMA, Paxlovid is the first orally administered antiviral drug recommended in the European Union for the treatment of Covid-19, containing two active substances in two different tablets that reduce the ability of the SARS-CoV-2 coronavirus to multiply in the body.

To reach the conclusion, the CHMP evaluated data from a study of infected patients, which showed that Paxlovid "significantly reduced hospitalisations or deaths in patients who have at least one underlying condition that puts them at risk of severe Covid-19".

Most patients participating in the study were infected with the Delta variant, but the EMA expects, based on laboratory research, that Paxlovid will also be active against Omicron and other SARS-CoV-2 variants.

"The CHMP concluded that the benefits of the drug outweigh its risks for approved use and will now forward its recommendations to the European Commission for a swift decision applicable in all EU member states," the regulator said.

It is now up to the European Commission to "expedite the decision-making process" to grant Paxlovid conditional marketing authorisation, allowing it to be marketed throughout the EU, the statement said.

This conditional marketing authorisation is a procedure used by the EMA to speed up the approval of medicines during public health emergencies in the EU, such as the current pandemic.

The European regulator is responsible for the scientific evaluation, supervision and monitoring of the safety of medicines in the EU, networking with thousands of experts across Europe, spread across the various scientific committees.