EMA receive marketing authorisation application for molnupiravir

The use of molnupiravir in COVID-19 cases aims to reduce the pressure on hospitals, in turn reducing the risk of patients developing more severe symptoms of the virus.

The European Medicines Agency (EMA) has begun evaluating an application for the marketing authorisation of molnupiravir, marketed as Lagevrio, an oral antiviral medicine for the treatment of COVID-19 in adults. The EMA will assess the safety and efficacy of Lagevrio under a reduced timeline and could issue an opinion on the treatment within weeks if the data on the benefits of Lagevrio are shown to sufficiently outweigh the risks.

This timeframe is possible because the EMA has reviewed a substantial portion of the medicine’s data during a rolling review. During this review, the Committee for Medicinal Products for Human Use (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.

The EMA’s Paediatric Committee (PDCO) has issued its opinion on the company’s paediatric investigation plan (PIP), which describes how the medicine should be developed and studied for use in children, coinciding with the accelerated timelines for COVID-19 products.

Lagevrio is an oral antiviral reducing the ability of SARS-CoV to multiply in the body. The drug introduces mutations in the genetic material, known as RNA, of SARS-CoV-2 during replication in a way that impairs the ability of the virus to multiply. Molnupiravir aims to lessen the burdens placed on hospitals through decreasing the number of hospitalised COVID-19 patients while reducing the risk of developing severe symptoms of COVID-19 in patients.

If the EMA concludes that the data submitted are sufficiently robust and complete to show the efficacy, safety and quality of the medicine 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 European Economic Area Member States within days.