EMA’s Rasi: Approval Decision For Remdesivir May Come ‘Very Soon’
Executive Summary
Speaking at a high-level European Parliament committee meeting today about COVID-19, the European Medicines Agency’s executive director indicated that Gilead would be submitting a conditional marketing authorization application for remdesivir in the EU.
You may also be interested in...
‘Not Yet But Shortly’: EU Remdesivir Filing
The European Medicines Agency has provided an update on the status of its review of Gilead’s investigational antiviral in the treatment of COVID-19.
Coronavirus Update: Rapid Japan Approval For Remdesivir, Combination With Lilly's Olumiant Is Next Hope
Plus: Chugai enters into Singapore research alliance, Korean consortium reports vaccine progress.
EMA Begins Rolling Review Of Remdesivir For COVID-19
Results from the US ACCT study have led both the EMA and the FDA to accelerate the review of Gilead’s remdesivir for use in coronavirus patients. The EMA says it will also take account of the results of a Chinese study that found the antiviral was “not associated with statistically significant clinical benefits.”