FDA issues emergency use authorization for remdesivir
President Trump welcomes the president of Gilead Pharmaceuticals to the White House; chief White House correspondent John Roberts reports.
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Coronavirus treatment remdesivir could reach hospitalized patients this week, says the CEO of developer Gilead.
Gilead CEO Daniel O’Day appeared on CBS’s “Face the Nation” on Sunday, explaining that the biotech intends to get the drug to coronavirus patients in the early part of this week.
On Friday, the FDA allowed emergency use of the antiviral drug to treat COVID-19 patients.
FDA ALLOWS EMERGENCY USE OF REMDESIVIR TO TREAT CORONAVIRUS PATIENTS AFTER PROMISING STUDY
During the interview, O’Day also said that Gilead has donated its entire supply of remdesivir to the U.S. government. “They will begin shipping tens of thousands of treatment courses out early this week and be adjusting that as the epidemic shifts and evolves in different parts, in different cities here in the United States,” he said.
Remdesivir has shortened the recovery time for COVID-19 patients, according to data from a study cited by the U.S. government last week.
“The data shows that remdesivir has a clear-cut significant positive effect in diminishing the time to recovery,” said Dr. Anthony Fauci, the government's top infectious-disease expert, during a White House press conference last week.
FAUCI SAYS EXPERIMENTAL CORONAVIRUS TREATMENT REMDESIVIR COULD SHORTEN COVID-19 RECOVERY TIME
A trend toward fewer deaths was seen among those on the drug, said Fauci. 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,” 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.”
The antiviral was previously used to treat Ebola patients and has been garnering massive attention as the world scrambles to contain the coronavirus pandemic. Experts, however, warn that people should not take drugs unless prescribed by a doctor.
EXPERIMENTAL CORONAVIRUS TREATMENT LERONLIMAB RESULTED IN 'REMARKABLE RECOVERIES,' DEVELOPER SAYS
In an open letter sent out last week, 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 a recent post on the clinicaltrials.gov website, officials explained that the primary metric for the Adaptive COVID-19 Treatment Trial (ACTT) of remdesivir sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) is patients’ time to recovery by day 29 of treatment.
EXPERIMENTAL CORONAVIRUS TREATMENT LERONLIMAB RESULTED IN 'REMARKABLE RECOVERIES,' DEVELOPER SAYS
The Washington Post reports that, previously, the trial’s primary metric was counting the number of people taking remdesivir who were kept alive on ventilators or died.
In a statement about the trial released on Feb. 24, the National Institutes of Health said that outcomes at day 15 of treatment were being scored on a seven-point scale ranging from fully recovered to death.
In the recent post, officials described the evaluation of patients using an eight-point scale, including death, need for ventilation, and recovery at day 15 as now a key secondary outcome of the trial.
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As of Monday morning, more than 3.52 million coronavirus cases have been diagnosed worldwide, at least 1,158,341 of which are in the U.S. The disease has accounted for at least 247,971 deaths around the world, including at least 67,886 people in the U.S.
The Associated Press contributed to this article. Follow James Rogers on Twitter @jamesjrogers
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