The European regulator said on Tuesday that it would vote within a few weeks on an application for authorization to market Merck's anti-Covid pill, molnupiravir, marketed under the name Lagevrio, on the European market.
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The EMA will assess the benefits and risks of Lagevrio within a short timeframe and may issue an opinion in a few weeks if the data submitted is strong and complete enough to show the efficacy, safety and quality of the drug,
" said the European Medicines Agency (EMA) said in a statement.
Read alsoThe EMA approves the emergency use of Merck's anti-Covid tablets
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The EMA will assess the benefits and risks of Lagevrio within a short timeframe and may issue an opinion in a few weeks if the data submitted is strong and complete enough to show the efficacy, safety and quality of the drug,
" said she added.
As Europe faces a new wave of the epidemic, the European regulator on Friday approved the use in an emergency, that is to say before its formal authorization within the EU, of the anti-Covid pill from Merck, and initiated a review for a similar authorization of Pfizer's anti-Covid pill.
Read also Pfizer to provide 10 million treatments of its anti-Covid pill in the United States
The two treatments from the US pharmaceutical giants are eagerly awaited, with studies indicating that they reduce the risk of hospitalization and death in patients at risk. Although Merck's tablet has yet to be approved, the EMA on Friday issued a recommendation so that individual EU countries can decide to use it when infections peak. "
If the EMA concludes that Lagevrio's benefits outweigh its risks in treating COVID 19, it will recommend (to the European Commission) granting a marketing authorization
," said the regulator, based in Amsterdam. The Merck pill decreases the ability of the coronavirus to multiply by increasing the number of mutations in its genetic material.