The European Medicines Agency (EMA) has conditionally approved the use of US multinational biotechnology firm Pfizer’s Covid-19 pill for treating adults at risk of severe illness.
The endorsement allows the member states of the European Union (EU) to deploy the drug after the EMA gave guidance for its emergency use late last year, Xinhua news agency reported.
The EMA said in a statement that its Committee for Medicinal Products for Human Use (CHMP) had “recommended granting a conditional marketing authorization for the oral antiviral medicine Paxlovid for treating Covid-19 in adults who do not require supplemental oxygen and who are at increased risk of the disease becoming severe.”
Paxlovid is the first oral antiviral recommended in the EU for treating Covid-19. It consists of two active substances packaged together. One reduces the ability of SARS-CoV-2 to multiply in the body, while the other enables the first substance to remain longer in the body at levels that affect the multiplication of the virus.
The EMA said it had evaluated data from a study involving patients with COVID-19, which showed that treatment with Paxlovid significantly reduced the risk of hospitalization and death among patients with at least one underlying condition.
Most patients involved in the study were infected with the Delta variant of coronavirus. Based on laboratory studies, Paxlovid is also expected to be effective against Omicron and other variants, the EMA said, adding that the pill’s side effects were mild.
The EMA’s recommendation was sent to the European Commission for a rapid decision applicable in all EU member states.