The experts of the European Medicines Agency (EMA) have supported this Friday the possible emergency use of the antiviral molnupiravir to treat COVID-19, which will be administered by decision of the authorities of the European Union (EU) countries, before the official license is authorized.
The European regulator stresses that this is advice to help decide on the possible early use of this pill before it receives its marketing authorization, such as in an emergency setting, “in light of the increase in infections and deaths for COVID-19 “in the EU.
The drug, known as Lagevrio and available in capsules, should be taken twice a day for 5 days, by adults with COVID-19 who do not require supplemental oxygen and who are patients at risk of developing the disease in its serious condition.
Recommends that this drug, which is still does not have an official license for use in the EU and is under a continuous review process, is administered “as soon as possible after diagnosis” of COVID-19 and within five days after the onset of symptoms, based on the findings of the committee of medicinal products for human use (CHMP).
The agency has reviewed the available data on drug quality and the results of the full and ongoing studies, as well as the interim results of the main study in non-hospitalized and unvaccinated patients with at least one underlying condition that puts you at risk of severe COVID-19.
According to that information, Lagevrio reduced the risk of hospitalization and death when administered at a dose of 800 mg twice daily and treatment started within five days of the onset of symptoms.
In terms of safety, side effects The most common reported during treatment and within two weeks after the last dose of molnupiravir were diarrhea, nausea, dizziness, and headache, all mild or moderate.
It is not recommended to take this drug during pregnancy, nor in women who may become pregnant or are not using effective contraception, while those who may become pregnant should use effective contraception while receiving this treatment and for four days after the last dose. , warns the EMA.
The same applies to breastfeeding, which must be interrupted during treatment and for four days after its end.
This oral antiviral, developed by the American pharmaceutical Merck Sharp & Dohme In collaboration with the biotechnology company Ridgeback Biotherapeutics, it reduces the ability of the virus to multiply in the body.
European countries can use this advice from the EMA to support recommendations on the possible use of this medicine, pending that the experts of the agency continue with the continuous evaluation and the pharmacist can eventually apply for a European license of use, which still does not have a defined calendar.
George Holan is chief editor at Plainsmen Post and has articles published in many notable publications in the last decade.