Will Merck’s anti-Covid pill be authorized in Europe? The European Medicines Agency (EMA) said in a statement on Tuesday that it had “started to assess a marketing authorization application for the oral antiviral drug Lagevrio (Molnupiravir)”. “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 emergency cases, that is to say before its formal authorization within the EU, of Merck’s anti-Covid pill, and initiated a review for a similar authorization of Pfizer’s anti-Covid pill.
A long-awaited swallow tablet
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.