EU grants conditional clearance to COVID-19 antiviral Remdesivir

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File photo of Giliead pharmaceuticals.
File photo of Giliead pharmaceuticals.

BRUSSELS — The European Commission said on Friday that it had given conditional approval for the use of COVID-19 antiviral Remdesivir following an accelerated review process and making it the first medicine authorized at EU level for treatment of COVID-19.

The authorization comes after a recommendation by the European Medicines Agency (EMA), followed by an endorsement by EU member states, the commission stated in a press release.

The EU executive said the drug, produced by Gilead, was the first medicine authorized in the European Union for treating COVID-19 following a "rolling review" begun by the EMA at the end of April.

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

Stella Kyriakides, EU Commissioner for Health and Food Safety, said, “Today’s authorization of a first medicine to treat COVID-19 is an important step forward in the fight against this virus.”

“We are granting this authorization less than a month after the application was submitted, showing clearly the WU’s determination to respond quickly whenever new treatments become available, she added.

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 US Department of Health and Human Services announced it had secured all of Gilead's projected production for July and 90 percent 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. — Agencies


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