EU body recommends authorizing Remdesivir for Covid-19 treatment

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

Remdesivir is the first medicine against COVID-19 to be recommended for authorization in the EU.

Data on remdesivir were assessed in an exceptionally short timeframe through a rolling review procedure, an approach used by EMA during public health emergencies to assess data as they become available.

From 30 April 2020, the CHMP began assessing data on quality and manufacturing, non-clinical data, preliminary clinical data and supporting safety data from compassionate use programmes, well in advance of the submission of the marketing authorization application on 5 June.

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