The European Medicines Agency (EMA) said on Thursday it has approved Pfizer’s anti-COVID pill, marketed as Paxlovid, which becomes the first antiviral medicine taken by mouth authorized in the European Union.
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“The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of a conditional marketing authorization for the orally taken antiviral medicine Paxlovid,” the European regulator said in a statement.
The EMA recommended “authorizing Paxlovid for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of the disease becoming serious”.
Antivirals work by decreasing the ability of a virus to replicate, thereby curbing disease. They are eagerly awaited because they are easy to administer and can be taken simply at home with a glass of water.
Pfizer said in December that its anti-COVID pill reduced hospitalizations and deaths in those at risk by nearly 90% when taken within the first few days after symptoms appear.
The EMA has assessed data from a study involving patients with COVID-19 showing that “Paxlovid treatment significantly reduced hospitalizations or deaths in patients who had at least one underlying condition putting them at risk at risk of severe COVID-19.
The majority of patients in the study were infected with the Delta variant, the EMA said, while stressing that according to laboratory tests, Paxlovid should remain effective against Omicron.
The Pfizer pill is a combination of a new molecule, PF-07321332, and ritonavir, an antiviral against HIV, which is taken in the form of separate tablets.
“The EMA’s Committee for Medicinal Products for Human Use has concluded that the benefits of the drug outweigh its risks for the approved use” and will “now send its recommendations to the European Commission for a rapid decision applicable in all states members of the EU”.
This approval procedure by the Commission generally takes a few hours or a few days.
“With the authorization of Paxlovid this week, 6 anti-COVID drugs have been authorized under the EU therapeutics strategy”, welcomed in a press release the European Commissioner for Health and Food Safety, Stella Kyriakides. .
The United States, Canada and Israel are among a handful of countries that have already given the green light to the Pfizer treatment.