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.
FILE PHOTO: Two ampules of Ebola drug Remdesivir are pictured during a news conference at the University Hospital Eppendorf in Hamburg, Germany, April 8, 2020, as the spread of coronavirus disease continues. Ulrich Perrey/Pool via REUTERS
“It might be that a conditional market 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. EMA’s recommendation on compassionate use matched an emergency authorisation granted by the U.S. Food and Drug Administration earlier in May, after Gilead provided data showing the drug had helped COVID-19 patients.The equivalent procedure in the U.S. is called “accelerated approval”, as opposed to the standard authorisation that the FDA grants to medicines which pass all tests before their marketing.
But it is still unclear how soon sufficient amounts of the drug could be available to meet the world’s need for a treatment.
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