The US Food and Drug Administration (FDA) has granted emergency use authorization for Gilead Science's antiviral drug remdesivir to treat Covid-19, US President Donald Trump said on Friday. Trump made the announcement during a meeting in the Oval Office of the White House with Gilead Chief Executive Daniel O'Day.
Remdesivir use in US hospitals
This move came after Gilead Sciences on Wednesday said that its Coronavirus treatment candidate remdesivir has succeeded in its critical trial, with 50 percent of the patients treated with the drug improved, while more than half were discharged within two weeks. The clinical trial included 397 patients with severe cases of novel Coronavirus infection.
During the White House meeting on Friday, O'Day told reporters: "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." He added that the company was donating 1.5 million vials of the drug to help patients. This donation is expected to be enough for at least 140,000 patients, depending on the number of days of their treatment.
A fact sheet from FDA on remdesivir revealed that the emergency use authorization means that remdesivir has not undergone the same level of review as an FDA-approved treatment. US doctors will be now allowed to use the potential Coronavirus drug on hospitalized COVID-19 patients, even though the drug has not been formally approved by the agency.
Earlier, the US health agency authorized the emergency use of malaria drugs chloroquine and hydroxychloroquine to treat Coronavirus patients but later, authorities issued a warning against taking the drugs outside a hospital or formal clinical trial setting after they received reports of serious heart rhythm problems in patients.
Remdesivir shows promising results against COVID-19
It should be noted that this week, White House health advisor Dr Anthony Fauci stated that the trials involving remdesivir showed "quite good news" and sets a new standard of care for Coronavirus patients. Even, the National Institute of Allergy and Infectious Diseases claimed that their study has shown that the patients with COVID-19 who took remdesivir usually recovered after 11 days, four days faster than those who did not take the medication.
Health and Human Services Secretary Alex Azar said in a statement Friday that NIH, FDA and scientists across the US as well as around the world "have worked tirelessly with patients to get us this new potential treatment for COVID-19," which has killed 238, 663 people and affected over 3.3 million individuals globally.
Earlier this week, President Trump said he wanted the FDA to move "as quickly as they can" to approve the drug. He said during a roundtable at the White House with business executives on Wednesday that "we would like to see very quick approvals, especially with things that work."
However, US health officials cautioned that while the anti-viral drug has not been formally approved to treat the deadly virus, new data on the remdesivir has yet to be peer reviews. It should be noted that even though the drug was granted for emergency use in hospitals, there are still several ongoing clinical trials testing remdesivir to see if it is effective enough to stop the Coronavirus from replicating.
The antiviral drug, which was created to treat Ebola, has been praised by several researchers after it showed impressive results in treating SARS and MERS, which are also caused by Coronaviruses. But like other drugs, remdesivir also can include side effects like nausea and vomiting as well as possible damage to the liver.
It should be noted that under the emergency use authorization, the FDA will allow the drug to be administrated for either a five-day or a 10-day dose. As reported by CNBC, former FDA Commissioner Scott Gottlieb said "that's going to allow Gilead to effectively double the supply."