EU may fast track remdesivir sale before US
BRUSSELS: 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 said on Monday, fast-tracking the drug to market amid tight global competition for resources.
The United States, 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 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 said on Monday at 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.
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.
Published in Dawn, May 19th, 2020