EMA’s Rasi: Approval Decision For Remdesivir May Come ‘Very Soon’
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.
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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.
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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.”