Studies have shown that the drug Paxlovid reduces the chances of hospitalization and death in patients with severe symptoms of Covid, and may also be effective against the mutant Omicron.
The European Medicines Agency said in a statement that it had “recommended the use of Baxlovid for the treatment of COVID-19 in adults who … are at increased risk of developing more severe symptoms of the disease.”
The United States, Canada and Israel are among a few countries that have given Pfizer the other light.
The European Commission must now formally license the drug in a routine procedure that usually takes hours or days.
“Baxulovide is the first antiviral drug in our portfolio to be taken at home, and can make a real difference in people at risk of developing advanced to severe Covid-19,” European Commissioner for Health Stella Kyriakides said in a statement.
“We also found promising evidence regarding the efficacy of baxlovid against omicron and other mutants,” she added.
Pfizer’s treatment is a combination of a new compound, PF-07321332, and the anti-HIV drug ritonavir, taken as tablets.
The agency said it “recommends the authorization of Baxlovid to treat COVID-19 in adults who do not need supplemental oxygen and who are at increased risk of developing more severe symptoms of the disease.”
The agency’s experts reviewed a study that “showed that treatment with Baxilovide significantly reduces the chances of hospitalization or death in people who already suffer from at least a disease, which puts them at risk of developing severe Covid-19 symptoms.”
Patients were given the pill within five days of symptoms appearing, and in the following month only 0.8 percent of the 1,039 people in the study were taken to hospital, compared to 6.3 percent of those who received a placebo.
No deaths were recorded in the group that received baxlovid compared to eight deaths in the group that received the placebo.
In December the European Medicines Agency allowed countries to independently decide whether to use baxlovid in early emergencies, but refrained from making a decision on full authorization in all EU countries.
The agency is still studying a similar request for the US company Merck’s anti-Covid drug.
Unlike vaccines, Fayez’s treatment does not target the constantly evolving spike protein that the coronavirus uses to invade cells.
So in theory, the drug should be more resistant to the mutant, and the company said it has preliminary laboratory studies that support this hypothesis.