Such a move by the European Medicines Agency (EMA) would open up a simple way for patients to be treated for this dangerous disease at home.
“The EEA will assess the benefits and risks of Lagevrio in the short term and could issue a conclusion in the coming weeks if the data provided is sufficiently robust and comprehensive,” the agency said in a statement.
Last week, the EEA stated that Community countries may use the COVID-19 oral drug, also known as molnupiravir, developed by Merck in the United States in certain cases, although it has not yet been officially approved.
“The drug, which is not currently authorized in the EU, can be used to treat COVID-19-infected adults who do not need extra oxygen and are at higher risk of developing severe COVID-19,” the agency said in a statement on Friday.
“The EEA has published this recommendation to assist national authorities in deciding on the possible early use of a medicine, for example in emergencies, in view of the growing number of COVID-19 infections and deaths across the EU before a marketing authorization is granted,” it said.
Merck oral medication should not be used by women who are pregnant or planning to become pregnant, the EVA said.
“These guidelines apply to laboratory tests on animals which have shown that [„Merck“ tablečių] high doses can affect fetal growth and development, ”the report added.
The UK became the first country to approve an oral anti-COVID-19 drug earlier this month. It allowed the use of molnupiravir in patients with mild to moderate coronavirus infection.