Rome, 25 November – EMA receives marketing authorization (Aic) application for molnupiravir (Lagevrio), the antiviral pill for the treatment of Covid-19 in adults, developed by Merck Sharp & Dohme (Msd, Merck in the US and Canada) in collaboration with Ridgeback Biotherapeutics.
The Community Regulatory Authority announces that it will assess the benefits and risks of the oral drug under investigation “In a short time and could issue an opinion within weeks, if the data presented are sufficiently reliable and complete to demonstrate the efficacy, safety and quality of the drug”.
“If the EMA concludes that the benefits from Lagevrio outweighs its risks for the treatment of Covid-19, will recommend the MA version. The European Commission will therefore speed up the decision-making process in order to be granted within a few days an authorization valid in all the Member States of the European Union and the European Economic Area “.
“A decision so fast” recalls the European Agency “It is possible only because the EMA has already considered a significant part of the drug data during the rolling review”, the ongoing cyclical review process according to which the results are analyzed as soon as they become available.
During this phase, The Committee for Medicinal Products for Human Use (CHMP) evaluated data from laboratory and animal studies, quality information on molnupiravir, mode of production and data on its efficacy and safety.. In addition, “The CHMP evaluated data from integrated and ongoing clinical trials, including the intermediate results of the main study on its effects Lagevrio in untreated and non-vaccinated patients with at least one underlying condition that exposes them to the risk of developing severe Covid “. At the end, “The Committee for Medicinal Products for Children (PDCO) has issued its opinion on the company’s Pediatric Research Plan, which describes how to develop and study the medicinal product for use in children, in accordance with the accelerated timelines for Covid products.”
Molnupiravir, by altering the genetic material of Sars-CoV-2 during its reproduction, works by reducing the ability of the coronavirus to multiply in the body. This should reduce the need for hospitalization for patients with Covid.
