On Monday 8 June, the European Medicines Agency (EMA) announced that it had received a conditional application for approval to use Remesivir as a treatment for Covid-19.
The drug, which was developed by Gilead Sciences and initially designed to combat the Ebola virus, does not yet have marketing approval in Europe, even though it is already being used in Europe for clinical trials and for compassionate use (for patients with no other medical options available).
The EMA has stated that it has officially started its risk/benefit assessment, after a first phase of continuous review by its scientific committees and working groups between 30 April and 15 May. The Commission has indicated that it might issue an opinion “within a few weeks”, depending on the robustness of the data that has been submitted and on whether additional information is needed to support the assessment.
If the assessment is conclusive, the EU agency has indicated that it would support an accelerated decision-making process and ultimately the Commission granting marketing approval that is valid in all EU and European Economic Area (EEA) Member States. (Original version in French by Sophie Petitjean)