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Remdesivir, which could shorten the recovery time for COVID-19 patients, is likely to receive emergency approval from the FDA, according to a New York Times report Wednesday.
The antiviral, which is developed by Gilead Sciences, was previously used to treat Ebola patients.
“As part of the FDA’s commitment to expediting the development and availability of potential COVID-19 treatments, the agency has been engaged in sustained and ongoing discussions with Gilead Sciences regarding making remdesivir available to patients as quickly as possible, as appropriate,” a spokesperson for the agency told Fox News via email Thursday morning.
On Wednesday the U.S. government cited data from a new study of the drug, which indicated its “positive” effect on COVID-19 patients.
Appearing on the “Today Show” Thursday, Dr. Anthony Fauci, the government's top infectious-disease expert, said that the FDA is “moving quickly” on issuing an approval.
Remdesivir has garnered widespread attention as America attempts to contain the coronavirus pandemic, particularly after the release of the data from the latest study.
“The data shows that remdesivir has a clear-cut significant positive effect in diminishing the time to recovery,” said Dr. Fauci, during a White House press conference on Wednesday.
A trend toward fewer deaths was seen among those on the drug, Dr. Fauci added. The study was run by the National Institutes of Health (NIH) and tested remdesivir versus usual care in 1,063 hospitalized coronavirus patients around the world. Fauci said patients on the drug took 11 days on average to recover versus 15 days for the others.
“It is a very important proof of concept because what it is proving is that a drug can block this virus,” Dr. Fauci added. “The mortality rate trended towards being better in the sense of less deaths in the remdesivir group – 8 percent versus 11 percent in the placebo group. It has not reached statistical significance but the data needs to be further analyzed.”
During his press conference, Dr. Fauci said that more information on remdesivir’s performance will be forthcoming. “Bottom line, you’re going to be hearing more details about this,” he said. “This will be submitted to a peer-review journal and will be peer-reviewed appropriately.
However, the disclosure of the trial results at this stage surprised some experts. Some scientists cited by the New York Times said that it was unusual to see trial results disclosed as they were in the White House press conference, before peer review or publication.
Additional details on the NIH trial emerged late Wednesday. In a statement, the University of Nebraska Medical Center and Nebraska Medicine explained that a total of about 450 people across 68 sites ultimately joined their study, which was part of the NIH trial. Some 47 of the sites were in the U.S. and 21 were in countries in Europe and Asia, they said, in a statement.
"My colleagues and I are pleased to be part of this study which is showing good preliminary results," said Dr. Andre Kalil, a professor of infectious diseases in the UNMC Department of Internal Medicine, who led the UNMC trial, in a statement. "We all are working diligently and swiftly to do the science in the appropriate way to help in this pandemic. It also gives us hope that soon this drug may be used widely."
At its National Quarantine Unit in Omaha, UNMC/Nebraska Medicine also housed 13 people who were repatriated Feb. 17 by the State Department from the Diamond Princess cruise ship. “Eleven of the 13 tested positive for COVID-19 and were monitored and have since been released,” UNMC/Nebraska Medicine said, in the statement.
In an open letter sent out on Wednesday evening, Gilead Sciences CEO Daniel O’Day said the results of the global trial run by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) are positive. “They show that patients with COVID-19 who received remdesivir recovered faster than similar patients who received placebo,” he said. There is still more work to do and remdesivir has not been approved, but all of us at Gilead are humbled by what these promising results might mean for patients.”
O’Day said that Gilead has been ramping up production of remdesivir since January. “Our existing supply, including finished product ready for distribution as well as materials in the final stages of production, amounts to 1.5 million individual doses,” he explained, in the statement. “We had estimated that this would be 140,000 treatment courses based on a 10-day treatment duration. The ability to shorten duration for severely ill patients means we can significantly increase the number of courses available, all of which Gilead has committed for donation.”
The various trials of remdesivir have come under intense scrutiny in recent weeks. Experts warn that people should not take drugs unless prescribed by a doctor.
Shares of Gilead rose more than 2 percent in pre-market trading on Thursday.
As of Thursday morning, more than 3.2 million coronavirus cases have been diagnosed worldwide, at least 1,040,488 of which are in the U.S. The disease has accounted for at least 228,057 deaths around the world, including at least 60,999 people in the U.S.
Fox News’ Matt Leach and the Associated Press contributed to this article. Follow James Rogers on Twitter @jamesjrogers