The European Medicines Agency (EMA) recommended today, 27 January, the marketing of paxlovid, which is the first oral antiviral to treat covid-19 in European Union countries.
“The EMA Committee for Human Medicines (CHMP) recommended granting a conditional marketing authorization for the oral antiviral drug paxlovid for the treatment of covid-19", says the European regulator in a statement.
According to the European agency, this drug from pharmaceutical Pfizer is recommended, at this stage, for adults who do not need supplemental oxygen and who are at greater 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 pills, which reduce the ability of the SARS-CoV-2 coronavirus to spread. multiply in the body.
To reach the conclusion announced today, the CHMP evaluated data from a study with infected patients, which showed that the paxlovid "significantly reduced hospitalizations or deaths in patients who have at least one underlying condition that puts them at risk for severe Covid-19."
The majority of patients participating in the study were infected with the Delta variant, but the EMA expects, based on laboratory research, that the paxlovid also be active against Ómicron and other variants of SARS-CoV-2.
"The CHMP has concluded that the benefits of the medicine outweigh its risks for the approved use and will now submit its recommendations to the European Commission for a rapid decision applicable in all EU Member States", the regulator added.
It is now up to the European Commission to "accelerate the decision-making process" to grant the conditional marketing authorization of paxlovid, allowing it to be marketed throughout the EU, the statement said.
This conditional marketing authorization is a procedure used by the EMA to accelerate drug approval during public health emergencies in the EU, such as the current pandemic.
The European regulator is responsible for the scientific assessment, supervision and monitoring of the safety of medicines in the EU, working in a network with thousands of experts from all over Europe, distributed across the various scientific committees.
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