“The ESA will assess the benefits and risks of Lagevrio in a reduced period of time and could issue an opinion within a week if the data submitted is sufficiently substantiated and complete,” the agency said in a statement.
As early as Friday, the ESA issued a recommendation allowing EU member states to decide for themselves whether to use Lagevrio, also known as molnupiravir, in an emergency, “given the rise in infections and deaths”.
The ESA is also evaluating the approval of Covid-19 tablets developed by Pfizer in a similar way.
Drugs developed by major US pharmaceutical companies could potentially be a major milestone in the fight against coronavirus, as studies show that they reduce the risk of hospitalization and death in high-risk people.
Merck pills should not be used by pregnant women who are not using contraception and may become pregnant, EZA said.
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