Gilead Sciences files MAA for remdesivir at the EMA to treat COVID-19.

The European Medicines Agency (EMA) reports that Gilead Sciences has submitted its marketing application seeking conditional approval of antiviral remdesivir for the treatment of COVID-19.

Since the EU regulator has already reviewed quality and manufacturing data, preliminary results from several clinical trial and supporting data from compassionate use programs, the review timeline will be shortened and the CHMP may issue an opinion “within weeks.”