EU may give green light to sale of Covid-19 treatment
The European Union may give an initial green light in the coming days for sale of the drug remdesivir as a Covid-19 treatment, the head of its medicines agency has said on Monday, fast-tracking the drug to market amid tight global competition for resources.
The US, which has angered the EU with aggressive tactics in a procurement race during the global pandemic, has yet to issue a similar approval for the drug, made by the US pharmaceutical company Gilead.
Demand for remdesivir has been growing as there are currently no approved treatments or vaccines for Covid-19, the respiratory illness caused by the new coronavirus.
“It might be that a conditional market(ing) authorisation can be issued in the coming days,” the head of the European Union’s medicines agency, Guido Rasi, told a hearing in the EU Parliament in Brussels.
An EU conditional marketing authorisation allows a drug to be sold for a year in the 27-nation bloc before all necessary data are available on its efficacy and side effects, Reuters reports.
The European Medicines Agency (EMA) has already recommended the compassionate use of remdesivir, which allows a drug to be administered to patients even before its sale has been authorised.
EMA’s recommendation on compassionate use matched an emergency authorisation granted by the US Food and Drug Administration (FDA) earlier in May, after Gilead provided data showing the drug had helped Covid-19 patients. But the EU is now moving rapidly to the next step in the authorisation procedure