EMA gives conditional approval to Pfizer’s new Covid-19 medication

The European Medicines Agency issued a conditional marketing authorization for Paxlovid, an antiviral treatment taken orally to treat Covid-19. Produced by Pfizer, the pills were approved for use in adults who tested positive for the coronavirus, and who do not yet need to be put on oxygen, but whose symptoms of the disease are worsening.

European Union Member States already had the ability to begin using Paxlovid as an emergency measure, but the Netherlands decided not to do this. Former Health Minister Hugo de Jonge said he preferred to wait for a decision by the EMA.

The treatment consists of a total of 30 pills administered over a five-day period. Two 150-milligram tablets of Paxlovid and one 100-milligram tablet of the drug ritonavir are to be given together to a patient twice daily. A single carton distributed by the company will include all pills required for the full course of treatment.

Paxlovid reduces the ability of the SARS-CoV-2 coronavirus to replicate in the body, while ritonavir extends the effectiveness of the Pfizer medication. This enables “it to remain longer in the body at levels that affect the multiplication of the virus,” the EMA stated in a press release.

Pfizer tested Paxlovid in combination with ritonavir in a study of about 2,100 patients, the EMA said, half of whom received a placebo. Only eight out of 1,039 Covid-19 patients given Paxlovid and ritonavir required hospitalization for longer than a day, or about 0.8 percent. None of them died. The study showed that 66 of the 1,046 people (6.3 percent) given a placebo required an extended hospital stay, and nine people died.

“The majority of patients in the study were infected with the Delta variant. Based on laboratory studies, Paxlovid is also expected to be active against Omicron and other variants,” the EMA said. Side effects were limited and mild, the EMA stated, though ritonavir is known to affect the outcome of taking other medications.

It is now up to the European Commission to approve the drug for use in the European Union. It has already been approved in the United States and the United Kingdom.