The EMA Human Medicines Committee has issued advice on the use of Lagevrio, a Merck pill (also known as molnupiravir) for the treatment of COVID-19
According to Coreper, the drug, which is not currently approved in the EU, can be used to treat adults with COVID-19 who do not need supplemental oxygen and are at increased risk of developing severe COVID-19.
Lagevrio should be given as soon as possible after diagnosis of COVID-19 and within 5 days of the onset of symptoms. The drug, which is available in capsules, should be taken twice a day for 5 days.
The EMA issued this advice to support national authorities who may decide on possible early use of the drug prior to marketing authorization, for example in emergency environments, in light of rising COVID-19 infection and death rates in throughout the EU.
The advice follows a review of the data, including data on drug quality and the results of comprehensive and ongoing studies. The interim results from the main study in non-hospitalized, non-vaccinated patients with at least one underlying condition that put them at risk for severe COVID-19 were evaluated as part of this advice.
Lagevrio, when administered at a dose of 800 mg twice daily, reduced the risk of hospitalization and death when treatment was started within 5 days of the onset of symptoms. About one month after starting treatment, 7.3% of patients (28 of 385) receiving Lagevrio compared with 14.1% (53 of 377) of placebo (placebo) had were hospitalized or had died. None of the patients in the Lagevrio group died compared to eight patients in the placebo group.
‼️ EMA issues advice to support 🇪🇺 countries who may decide on early use of the oral antiviral molnupiravir.
— EU Medicines Agency (@EMA_News) November 19, 2021
Side effects – Not recommended for pregnant women
In terms of safety, the most common side effects reported during treatment and within 14 days of the last dose of Lagevrio were diarrhea, nausea, dizziness, and headache, all of which were mild or moderate.
Lagevrio is not recommended during pregnancy and in women who may become pregnant and are not using effective contraception. Women who can become pregnant should use effective contraception during treatment and for 4 days after the last dose of Lagevrio. Breastfeeding should be discontinued during treatment and for 4 days after treatment. These recommendations are given as laboratory studies in animals have shown that high doses of Lagevrio can affect fetal development.
The Agency’s advice can now be used to support national recommendations regarding the possible use of the medicinal product prior to marketing authorization.
Source From: Capital