Lima, November 24, 2021Updated on 11/24/2021 10:46 am
The European Medicines Agency (EMA) began on Tuesday to evaluate the application for a marketing license in the European Union (EU) presented today by the developers of the antiviral Lagevrio (molnupiravir), an oral drug to treat COVID-19 in patients Adults.
The European regulator “Evaluate the benefits and risks” from Lagevrio “In a short time” and it could issue an opinion on the license in “a few weeks” if the data submitted by the drug companies is robust and complete enough to demonstrate the drug’s efficacy, safety and quality.
The conclusion of the EMA It will be achieved in a shorter time because the committee for medicinal products for human use (CHMP) has already carried out work in recent weeks, during the continuous evaluation of the drug.
The CHMP has already evaluated data from laboratory and animal studies, information on the quality of the drug and how it will be produced, data on its efficacy and safety, and the results of completed and ongoing clinical studies.
These included the interim results of the main study on the effects of Lagevrio in non-hospitalized and unvaccinated patients with at least one underlying condition that puts them at risk of developing severe COVID-19.
Based on that information, Lagevrio it reduced the risk of hospitalization and death when given at a dose of 800 mg twice daily and treatment started within five days of symptom onset.
Lagevrio, developed by the American pharmaceutical company Merck Sharp & Dohme In collaboration with biotech Ridgeback Biotherapeutics, it reduces the ability of the coronavirus to multiply in the body, according to studies, and is intended to treat COVID-19 in adults.
On the 19th, the experts of the EMA have endorsed the possible emergency use of the molnupiravir on the EU, which will be administered by decision only of the national authorities, before the official European license is authorized, a scientific endorsement from the agency to help decision-making “in light of the increase in infections and deaths” by COVID-19.
The drug, 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.
The CHMP recommended that this drug be administered “as soon as possible after diagnosis” of the COVID-19 and within five days of the onset of symptoms.