EMA reviewing molnupiravir data for COVID-19

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have agreed on the need for additional guidance on COVID-19 treatments in light of rising rates of infection and deaths due to COVID-19 across the EU.

To this end, the EMA is reviewing available data on the use of US pharma giant Merck & Co’s molnupiravir (also known as MK 4482 or Lagevrio) to support national authorities who may decide on the use of this medicine for COVID-19 treatment prior to its authorization.

While the more comprehensive rolling review is ongoing ahead of a possible application for a marketing authorization, the EMA’s Committee for Medicinal Products for Human Use (CHMP) will provide EU-wide recommendations in the shortest possible timeframe to help national authorities decide on possible early use of the medicine, for example, in emergency use settings.