Instructions for the use of Lagevrio (also known as molnupiravir – molnupiravir) for the treatment of COVID-19 were issued on Friday by the Human Medicines Committee (CHMP) of the EMA (European Medicines Agency).
According to Coreper, the drug, developed by Merck Sharp & Dohme (known in Europe as MSD) and not currently approved in the EU, can be used to treat adults with COVID-19 who do not need supplemental oxygen and who 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 directive to support national authorities that may decide on possible early use of the medicinal product prior to marketing authorization, for example in emergency use environments, in light of rising COVID-19 infection and death rates in throughout the EU.
The directive follows the review of 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 guideline. 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.
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 either 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 proposed EMA Terms of Use will be posted shortly on the EMA website.
The Agency’s guidelines can now be used to support national recommendations regarding the possible use of the medicinal product prior to marketing authorization.
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