Following the EMA's interim recommendations to support national authorities that may decide on the early use of Lagevrio (molnupiravir) prior to marketing authorisation approval, the Agency will evaluate more data from the main study of Lagevrio (MK-4482-002).
The above-mentioned recommendations issued by the EMA in November 2021 in the context of an assessment under Article 5(3) were based on the interim data available at the time of the review from that study. . These data from 762 subjects showed that Lagevrio reduced the risk of hospitalization or death in subjects with COVID-19 who were at higher risk of serious disease from 14, 1% in the placebo (placebo) group to 7, 3% in the group receiving Lagevrio. The study did not include people who had been vaccinated.
The updated results, based on 1,408 people, show that Lagevrio reduced the risk of hospitalization or death in people with COVID-19 disease who were at greater risk of serious disease from 9.7% in the placebo group to 6.8% in the Lagevrio group. The EMA will evaluate these data in the context of a more comprehensive marketing authorisation application.
The previous recommendations are not varied. EMA will further communicate the outcome of the marketing authorisation application currently under review.
More about the drug
Lagevrio is an oral antiviral drug that reduces the ability of SARS CoV 2 (the virus that causes COVID-19 disease) to replicate in the body. It does this by increasing the number of alterations (mutations) in the genetic material of the virus (known as RNA), in a way that adversely affects the ability of SARS-CoV-2 to replicate.
Lagevrio is being developed by Merck Sharp & Dohme in collaboration with Ridgeback Biotherapeutics.
(AF)
Contents of this article including associated images are owned by PIO
Views & opinions expressed are those of the author and/or PIO
Source
