Europe – Rasi: EMA may conditionally authorize remdesivir in the ‘coming days’

The European Medicines Agency’s (EMA) Executive Director Guido Rasi on Monday told a European Parliament committee that the agency could grant conditional marketing authorization to Gilead Sciences’ remdesivir to treat coronavirus disease (COVID-19) in a matter of days.

“It might be that a conditional marketing authorization can be issued in the coming days, subject to the data that has been submitted,” Rasi said, adding that he does not believe the drug is ready to receive a standard marketing authorization at this stage.
Rasi’s remarks come after EMA initiated a rolling review or remdesivir earlier this month and a week after the agency recommended wider compassionate use of the drug. (RELATED: EMA kicks off rolling review of Gilead’s remdesivirRegulatory Focus 1 May 2020; Remdesivir: EMA recommends wider compassionate useRegulatory Focus 11 May 2020)…