The European Medicines Agency (EMA) announced Tuesday that it will look into more data on the administration of the antiviral drug Lagevrio (molnupiravir) against COVID-19, which is being developed by Merck Sharp & Dohme in collaboration with Ridgeback Biotherapeutics. The EMA will evaluate this data as part of a more comprehensive marketing authorization application.
“Following the EMA’s interim recommendations to support national authorities that may decide to use Lagevrio (molnupiravir) pre-marketing authorization, the Agency will consider more data from the main Lagevrio study,” the statement said.
The recommendations issued by the EMA in November 2021 were based on an evaluation of the intermediate data available. These data, based on 762 people, showed that Lagevrio reduced the risk of hospitalization or death in people with COVID-19 who had a higher risk of serious illness from 14.1% in the placebo group to 7.3% in Lagevrio team. The study did not include people who had been vaccinated.
Updated results, based on 1,408 people, show that Lagevrio reduced the risk of hospitalization or death in people with COVID-19 who had a higher risk of serious illness from 9.7% in the placebo group to 6.8% in the Lagevrio group .
Previous recommendations remain unchanged. The EMA will further inform you of the outcome of the marketing authorization application under consideration.
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