The European Medicines Agency (EMA) has given the green light for the use of Paxlovid, the anti-Covid pill developed by Pfizer, on Thursday.
The EMA had already given approval for emergency use in mid-December but as soon as the European Commission officially adopts the advice, Paxlovid will now also receive conditional marketing authorisation.
“Pending conditional marketing authorisation from the European Commission, we will continue working closely with EU Member State governments to ensure this important treatment can be made available to patients across Europe as quickly as possible,” said Pfizer’s CEO Albert Bourla in a press release.
The EMA recommended authorising Paxlovid for treating Covid-19 in infected adults who are at increased risk of becoming severely ill but do not require supplemental oxygen.
The pill is the first antiviral medicine to be given orally that is recommended in the EU for treating Covid-19, and contains two active substances: PF-07321332 and ritonavir, in two different tablets. They should be taken together twice a day for five days.
The EMA’s decision is based on a study showing that Paxlovid significantly reduces the risk of hospitalisation and death in patients with at least one underlying condition. In most cases, the test subjects had contracted an infection with the Delta variant, but lab studies show that Paxlovid would work equally well against the Omicron variant, stated EMA.
Pfizer’s Covid-19 pill had already been given the green light in the United States and the United Kingdom. Now, the European Commission will fast-track the decision-making process to grant a decision on the conditional marketing authorisation for Paxlovid, allowing this medicine to be marketed across the EU.