BRIEF—First COVID-19 treatment recommended for EU authorization

The European Medicines Agency’s human medicines committee (CHMP) has recommended granting a conditional marketing authorization to Veklury (remdesivir) for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen.

Gilead Sciences’ remdesivir is the first medicine against COVID-19 to be recommended for authorization in the European Union. Data on remdesivir were assessed in an exceptionally short timeframe through a  rolling review procedure, an approach used by the EMA during public health emergencies to assess data as they become available. From April 30, 2020, the CHMP began assessing data on quality and manufacturing, non-clinical data, preliminary clinical data and supporting safety data from compassionate use programs, well in advance of the submission of the marketing authorization application on June 5.

The assessment of the dossier has now concluded with today’s recommendation, which is mainly based on data from study NIAID-ACTT-1, sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID), plus supporting data from other studies on remdesivir.