Europe – EMA receives application for marketing authorisation for Lagevrio (molnupiravir) for treating patients with COVID 19

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.

EMA will assess the benefits and risks of Lagevrio under a reduced timeline and could issue an opinion within weeks if the data submitted are sufficiently robust and complete to show the efficacy, safety and quality of the medicine.

Such a short timeframe is only possible because EMA has already reviewed a substantial portion of the data on the medicine during a rolling review. During this phase, EMA’s human medicines committee (CHMP) assessed data from laboratory and animal studies (non-clinical data), information on the quality of the medicine and the way it will be produced, and data on its efficacy and safety. In addition, CHMP assessed data from completed and ongoing clinical studies. These include interim results from the main study on the effects of Lagevrio in non-hospitalised, unvaccinated patients with at least one underlying condition putting them at risk of severe COVID-19…