According to Reuters, Gilead CEO Daniel O'Day called the FDA's emergency authorization an "important first step" and pledged to donate "1 million vials of remdesivir." US Vice President Mike Pence also said that 1 million vials of remdesivir will be distributed to hospitals starting Monday.
— Mark Knoller (@markknoller) May 1, 2020
"I'm pleased to announce that Gilead now has an [emergency authorization] from the FDA for remdesivir. And you know what, that is because that's been the then the hot thing, also in the papers and in the media for the last little while — an important treatment for hospitalized coronavirus patients," Trump said Friday in reference to the drug's authorization.
FDA Commissioner Stephen Hahn also called the authorization of remdesivir to treat the novel coronavirus "an important clinical advance," Reuters reported.
The FDA authorization comes just two days after Gilead Sciences revealed it was aware of “positive data” from a clinical trial by the US National Institute of Allergy and Infectious Diseases of the antiviral drug as a COVID-19 treatment.
The institute is led by Anthony Fauci, one of the leading doctors assigned to the White House Coronavirus Task Force. During a Wednesday meeting in the Oval Office, Fauci indicated that the drug trial showed that remdesivir has had a significant effect on reducing coronavirus symptoms.
"The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery," Fauci said on Wednesday.
According to the FDA's fact sheet, approval of remdesivir simply means that the drug "may be effective in treatment of patients." The FDA also notes that "remdesivir has not undergone the same type of review as an FDA-approved or cleared product" since the drug was issued an "Emergency Use Authorization" (EUA).
"FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives. In addition, the FDA decision is based on the totality of scientific evidence available showing that it is reasonable to believe that the product meets certain criteria for safety, performance, and labeling and may be effective in treatment of patients during the COVID-19 pandemic. All of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19 pandemic," the FDA explains.
Also on Wednesday, former FDA Commissioner Scott Gottlieb said that that remdesivir is probably not a “home run” treatment for the novel coronavirus, but can help alleviate symptoms.
“It’s not going to be a cure, but it is going to be a drug potentially that if you use it particularly early in the course of a disease - you hang it in the emergency room when someone comes in with COVID, especially someone with risk factors that predict they’ll have a worse outcome from the disease - it could reduce their chances of having a really bad outcome,” he said in a statement to CNBC.
However, it appears as though the drug may have side effects in some patients.
According to the Financial Times, a Chinese trial indicated that remdesivir did not improve patients’ conditions or decrease the amount of COVID-19 in their bloodstreams. Out of a group of 237 patients, 158 were given the drug, while the remaining 79 were part of the control group. Eighteen patients who received the drug experienced adverse side effects and had to stop taking it. Gilead said that trial was terminated due to an insufficient number of participants.
However, the FDA on Friday revealed that its "reasonable" to believe that the benefits of remdesivir "outweigh risks" for the "treatment of patients hospitalized with severe COVID-19," Reuters reported.
Remdesvir was initially developed by Gilead as a potential treatment for Ebola; however, it failed to treat the disease, which causes severe bleeding and organ failure. The drug has been experimentally shown to be effective at inhibiting the growth of coronaviruses that cause illnesses similar to COVID-19, including severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS).
Although remdesivir may help alleviate coronavirus symptoms, it is not a cure; researchers around the globe are still racing to develop a vaccine.
The University of Oxford expects to have the first indication of whether its COVID-19 vaccine - called ChAdOx1 nCoV-19 - works on humans in mid-June. Human trials for the coronavirus vaccine developed by the university began on April 23, after the drug showed promising results by protecting six rhesus macaque monkeys from large amounts of COVID-19 in late March. Around 1,100 people are currently part of the trial.
The World Health Organization revealed last Thursday that there are a total of at least six COVID-19 vaccines that have entered human trials, and 77 others are still in various stages of development.
