EU conditionally approves remdesivir as COVID-19 treatment
The European Commission has conditionally approved the antiviral medication remdesiver as a treatment for COVID-19.
The drug is the only therapy authorized to treat COVID-19 patients by the U.S.Food and Drug Administration (FDA), and now the only one approved in Europe. Gilead, the drugmaker that produces remdesiver, said Friday that Japan, Taiwan, India, Singapore and the United Arab Emirates are also using the drug to treat COVID-19.
EU officials said that they passed the conditional approval in less than a month, “showing clearly the EU’s determination to respond quickly whenever new treatments become available.”
“We will leave no stone unturned in our efforts to secure efficient treatments or vaccine against the coronavirus,” Stella Kyriakides, EU Commissioner for Health and Food Safety, said in a statement.
In the U.S., remdesiver is used on COVID-19 patients experiencing severe symptoms, and trials have shown fairly modest results. A five-day course of remdesivir will cost the U.S. government and other developed countries $2,340 per patient, the drugmaker Gilead announced this week.
The Commission said it was in negotiations with Gilead to obtain doses of remdesivir for the 27 European Union countries.
The conditional marketing authorization, such as the one the EU granted to remdesiver, is a regulatory mechanism put in place to facilitate early access to medicines that fulfill an unmet medical need.