The European health regulator said on Monday it would look to fast-track the approval of Gilead Sciences Inc’s antiviral remdesivir as a potential COVID-19 treatment in Europe after the U.S. drugmaker submitted its marketing application.
Remdesivir, the first drug to show improvement in COVID-19 patients in formal trials, has been cleared for emergency use in severely-ill patients in the United States, India and South Korea. Some European nations are also using it under compassionate programmes.
“The assessment of the benefits and risks of remdesivir is being performed under a reduced timeline and an opinion could be issued within weeks,” the European Medicines Agency (EMA) said in its statement.
The EMA last month told the European Parliament it may give an initial green light for sale of remdesivir as a COVID-19 treatment, bringing the drug to market as early as possible.
The agency said on Monday speedy assessment of the drug was possible because some data was already being reviewed by the regulator’s human medicines committee as part of a rolling review.
If approved, Gilead’s drug, given intravenously, would be the first approved COVID-19 treatment in Europe. Final approvals are up to the European Commission, which generally endorses EMA recommendations.