The European Medicines Agency (EMA) announced on Monday that it had started examining an application for authorization in the EU for the anti-COVID pill from the American pharmaceutical company Pfizer, specifying that an opinion could be issued in “a few weeks”.
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The EMA approved in December the emergency use in the European Union of the treatment, known as Paxlovid, in order to support the national authorities, which can decide on the possible early use of the drug.
The EMA said it has now started to “assess an application for a conditional marketing authorization” for Paxlovid.
“The EMA will assess the benefits and risks of Paxlovid within a short timeframe and may issue an opinion in a few weeks,” the agency said, adding that the timing would depend on whether Pfizer’s data is “robust enough”.
Antivirals work by reducing the ability of a virus to replicate, thereby slowing down the disease. They are eagerly awaited because they are easy to administer and can be taken at home with a glass of water.
The EMA has also issued an emergency use authorization for a pill from Pfizer’s rival, Merck, and is considering an application for general authorization from the company.
Both drugs have been hailed as potentially revolutionary in the fight against COVID-19, as studies show they reduce the risk of hospitalization and death in patients at increased risk of developing a severe form of the disease.
The United States cleared the Pfizer and Merck pills in December.
The Pfizer pill is a combination of a new molecule, PF-07321332, and the antiviral HIV ritonavir, which are taken as separate tablets.