The European Medicines Agency (EMA) Thursday announced it had approved the use of Pfizer's anti-COVID-19 pill Paxlovid, which has thus become the first oral treatment cleared for use in the European Union. The new drug is a combination of the molecule PF-07321332 and the HIV antiviral Ritonavir.
”The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of a conditional marketing authorization for the oral antiviral drug Paxlovid, an statement read.
The sanitary agency recommended authorizing Paxlovid for the treatment of COVID-19 in adults who do not require supplementary oxygen and who are at increased risk of the disease becoming severe, the statement also pointed out.
Antivirals work by reducing the ability of a virus to replicate itself, thereby curbing the disease. The United States, Canada and Israel are some of the countries that already use it.
Pfizer had declared in December that its anticovid pill reduced hospitalizations and deaths in people at risk by almost 90% when taken in the first days after the onset of symptoms.
This medication is easy to administer, and can simply be taken at home with a glass of water.
In granting its conditional marketing authorization, the EMA assessed data from a study involving COVID-19 patients showing that treatment with Paxlovid significantly reduced hospitalizations or deaths in patients who had at least one underlying condition putting them at risk of severe COVID-19, it was reported.
Most patients in the study were infected with the Delta variant, the EMA said, while noting that laboratory tests indicate that Paxlovid should remain effective against Omicron.
The EMA's Committee for Medicinal Products for Human Use has concluded that the benefits of the medicine outweigh its risks for the approved use, and will now send its recommendations to the European Commission for a rapid decision applicable in all EU Member States, the regulator said.
With the approval of Paxlovid this week, six anti-COVID drugs have been authorized as part of the EU's therapeutic strategy,” European Commissioner for Health and Food Safety Stella Kyriakides said.