BREAKING: First COVID-19 Treatment Recommended For EU Authorisation

The European Medicines Agency has announced that Remdesivir is the first medicine against COVID-19 to be recommended for authorisation in the EU.

Data on remdesivir was 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 authorisation application on 5 June.

The European Commission, which was kept informed by EMA throughout the evaluation, will fast-track the decision-making process and aims to grant a decision on the conditional marketing authorisation for remdesivir in the coming week, allowing the product to be marketed in the EU.

 

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