The US Government This Friday authorized the use of the antiviral drug Remdesivir to treat the most serious patients with COVID-19, despite the fact that its own manufacturer, Gilead, has warned that it has not yet been proven to be safe and there are studies that indicate that its efficacy has not is clear.
US President Donald Trump was tasked with announcing that the drug had received an “emergency authorization” from the US Food and Drug Administration. (FDA), the government agency that approves the use of products related to public health.
“It is a pleasure to announce that Gilead now has an FDA emergency authorization for Remdesivir. And they know that this happens because it has been the hottest thing in the newspapers and in the media for a while. It is an important treatment for hospitalized patients with coronavirus, “said Trump.
The president considered that the antiviral offers a “promising situation” and explained that it will only be used to treat hospitalized patients with coronavirus who are in serious condition.
Trump made those remarks in the presence of Gilead CEO Daniel O’Day, who was pleased with the approval, and announced that his company will donate a million doses to help people infected with the virus.
This week, Trump had already expressed a desire that the FDA, which is theoretically an independent agency, speed up the approval process for the drug, which is administered intravenously.
In a statement, the FDA admitted Friday that there is “limited information” about the safety and efficacy of Remdesivir for treating coronavirus, but explained that it has authorized its application because a recent clinical trial showed that the drug shortens recovery time in some patients.
Specifically, that trial – conducted at the National Institutes of Health (NIH) – showed that patients hospitalized with COVID-19 who were administered Remdesivir (1,063 patients overall) had a 31% faster recovery , specifically 11 days, than those who received placebo, which took an average of 15 days to recover.
The authorization means that, from now on, the antiviral will be able to be injected to patients with COVID-19 who are admitted to hospitals in serious condition, which the FDA defines as the need for assistance to breathe, for example, with a ventilator. .
In another statement this Friday, Gilead, based in Foster City, California, was cautious and stated that the effectiveness of Remdesivir is still being investigated.
In addition, he recalled that the optimal dose and duration of treatment is still unknown, although at the moment under the authorization of the FDA the antiviral will be administered to patients for 5 or 10 days, depending on their condition.
Gilead indicated that priority will be given to the most affected areas, so the drug is expected to arrive in New York City, the epicenter of the US pandemic, soon. with more than 313.00 cases and 23,800 deaths.
Across the country, more than a million people have been infected and more than 64,000 have died, according to the unofficial count by Johns Hopkins University.