The European Medicines Agency (EMA) announced on Tuesday beginning to review marketing authorization for the Lagevrio antiviral medicine for treatment of COVID-19 patients
MOSCOW (UrduPoint News / Sputnik – 23rd November, 2021) The European Medicines Agency (EMA) announced on Tuesday beginning to review marketing authorization for the Lagevrio antiviral medicine for treatment of COVID-19 patients.
“EMA has started evaluating an application for marketing authorisation for the oral antiviral medicine Lagevrio (molnupiravir). Lagevrio, which is being developed by Merck Sharp & Dohme in collaboration with Ridgeback Biotherapeutics, is intended for the treatment of COVID-19 in adults,” the agency said in a statement.
According to EMA, it will look into the medicine under a shortened timeline as it has already reviewed a significant portion of the data during a rolling review.
Because of that, the decision could be made within several weeks.
“If EMA concludes that the benefits of Lagevrio outweigh its risks in treating COVID 19, it will recommend granting a marketing authorisation. The European Commission will then fast-track its decision-making process with a view to granting a marketing authorisation valid in all EU and EEA (European Economic Area) Member States within days,” the agency added.
At the moment, three medicines Regkirona, Ronapreve and Veklury are authorized as COVID-19 treatments in the European Union.