8 June 2020 - EMA has now received an application for conditional marketing authorisation of the antiviral medicine remdesivir for the treatment of COVID-19 and has formally started its evaluation.
The assessment of the benefits and risks of remdesivir is being performed under a reduced timeline and an opinion could be issued within weeks, depending on the robustness of the data submitted and whether further information is required to support the evaluation.
Such a short timeframe will only be possible because some data have already been assessed during the first cycle of the rolling review, which started on 30 April and was concluded on 15 May.