EMA starts review to support possible national decisions on early use
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, EMA is reviewing available data on the use of 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 authorisation.
While the more comprehensive rolling review is ongoing ahead of a possible application for a marketing authorisation, 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.
Molnupiravir is an oral antiviral medicine developed by Merck Sharp & Dohme in collaboration with Ridgeback Biotherapeutics.
EMA and HMA remain committed to expediting the evaluation of much needed COVID-19 treatments and vaccines, while ensuring these meet the EU’s high standards of safety and efficacy. EMA will communicate on the outcome of this review and that of the rolling review once they conclude.