Gilead Gets Emergency US FDA Approval For Its Antiviral Remdesivir To Treat COVID-19
USA's Food and Drug Administration (FDA) has granted emergency use authorization for Gilead Sciences' investigational antiviral drug Remdesivir to treat COVID-19.
The global stock markets, including Indian benchmark indices, had surged this week after Gilead said that its new clinical trial of the intravenous drug showed that it has helped shorten the recovery time of at least 50 percent of the hospitalized COVID-19 patients treated with it.
The announcement of the emergency use authorization was made by US President Donald Trump at the Oval Office on Friday (Washington time) alongside Gilead CEO Daniel O'Day. Gilead will be donating 1.5 million vials of Remdesivir.
The authorization granted is temporary and Gilead will have to go through the usual process of new drug application submission, review and approval process of the US FDA. It still remains an investigational drug and has not been approved by the regulator, Gilead said.
However, doctors will be permitted to use the drug on patients hospitalized with the disease.
Previously, FDA previously had authorized the emergency use of malaria drugs chloroquine and hydroxychloroquine to treat COVID-19. However, it later issued a warning against taking the drugs outside a hospital or formal clinical trial setting after reports of "serious heart rhythm problems" in patients.
As per data compiled by John Hopkins University, the coronavirus pandemic has infected more than 3.3 million people and killed at least 2,37,000 across the world. In India, the case count has crossed 37,000-mark with the death toll at 1,218.