EU grants conditional clearance to COVID-19 drug remdesivir

The European Commission said on Friday it had given conditional approval for the use of COVID-19 antiviral remdesivir following an accelerated review process.

The EU executive said the drug, produced by Gilead Sciences Inc (GILD.O), was the first medicine authorised in the European Union for treating COVID-19 following a “rolling review” begun by the European Medicines Agency at the end of April.

The agency reviews data as they become available on a rolling basis, while development is still ongoing.

The Commission said on Wednesday it was in negotiations with Gilead to obtain doses of remdesivir for the 27 European Union countries.

However, that may prove difficult after the U.S. Department of Health and Human Services announced it had secured all of Gilead’s projected production for July and 90% of that for August and September.

Remdesivir is in high demand after the intravenously-administered medicine helped to shorten hospital recovery times in a clinical trial.

It is believed to be most effective in treating COVID-19 patients earlier in the course of disease than other therapies like the steroid dexamethasone.

Still, because remdesivir is given intravenously over at least a five-day period it is generally being used on patients sick enough to require hospitalisation.

Reporting by Philip Blenkinsop, editing by Marine Strauss and Jane Merriman