The Food and Drug Administration (FDA) granted an emergency authorization for Gilead’s remdesivir to treat the CCP virus, said President Donald Trump on Friday.
Trump made the announcement alongside Gilead’s CEO, Daniel O’Day, saying that it is “an important treatment for hospitalized coronavirus patients … it’s really a promising situation.”
“We want to thank the collaborators that brought remdesivir to this point and many of our people that have been part of this, in fact, the caregivers,” O’Day told reporters in the White House’s Oval Office, adding that the company will donate one million vials of the drug, which was originally developed for Ebola and Marburg virus to no avail.
The announcement came after preliminary data in a clinical study showed the drug helps speed recovery from the CCP (Chinese Communist Party) virus, a novel coronavirus that originated in mainland China that causes the disease COVID-19.
“FDA’s emergency authorization of remdesivir, two days after the National Institutes of Health’s clinical trial showed promising results, is a significant step forward in battling COVID-19 and another example of the Trump Administration moving as quickly as possible to use science to save lives,” Health and Human Services Secretary Alex Azar said in a statement in announcing the confirmation.
Azar said that the FDA and other scientists have “worked tirelessly with patients to get us this new potential treatment for COVID-19.”
The emergency authorization doesn’t mean that remdesivir has undergone the same level of review as an FDA-approved treatment, according to the agency’s website. Doctors can use the antiviral medication on patients who are hospitalized with COVID-19.
Previously, the anti-malarial drugs chloroquine and hydroxychloroquine were approved by the FDA to treat the CCP virus. But later, the agency warned against taking the drugs outside of a hospital or clinical trial setting after some patients reported serious heart rhythm issues.
The study about remdesivir’s effects on COVID-19 patients was hailed by White House pandemic task force member Dr. Anthony Fauci this week.
“The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery,” Fauci said on April 29 as he met with Trump and Louisiana Gov. John Bel Edwards.
Trump, meanwhile, has said the drug has potential to treat COVID-19, which has infected more than 1 million people in the United States and killed at least 60,000.
“We would like to see very quick approvals, especially with things that work,” he told reporters at a meeting in the White Hosue on Wednesday.
Gilead on Thursday said it can produce several million doses of the drug in 2021. By the end of May, more than 140,000 rounds of a 10-day treatment regimen of the drug are expected to be completed, the firm also said.
“Our focus at this time is on both our work with remdesivir and our ongoing commitments to the people who depend on our medicines today,” O’Day said.
From The Epoch Times
