14 December 2021 - Following EMA’s interim recommendations to support national authorities who may decide on early use of Lagevrio (molnupiravir) prior to marketing authorisation, the Agency will review more data from the main study of Lagevrio (MK-4482-002).

The above recommendations issued by EMA in November 2021 in the context of an Article 5(3) review were based on an assessment of interim data from this study which were available at the time of the review. These data, based on 762 subjects, showed that Lagevrio reduced the risk of hospitalisation or death in people with COVID-19 who were at higher risk of severe disease from 14.1% in the placebo (dummy treatment) group to 7.3% in the Lagevrio group. The study did not include people who had been vaccinated.

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