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President Trump announced Friday that the Food and Drug Administration (FDA) has authorized the emergency use of Gilead Science’s experimental antiviral drug remdesivir to treat coronavirus patients after early results of a clinical study indicated the drug helps speed recovery.
Trump announced the news at the White House alongside Gilead CEO Daniel O’Day and FDA Commissioner Stephen Hahn.
“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.
“NIH, FDA, and scientists across America and around the world have worked tirelessly with patients to get us this new potential treatment for COVID-19,” he added. “The seamless cooperation between government and private industry under the President’s all-of-America approach to COVID-19 is getting treatment options to patients in record time.”
The emergency use order allows the drug to be distributed to health care providers and administered to hospitalized COVID-19 patients.
“Today’s action is an important step in our efforts to collaborate with innovators and researchers to provide sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective,” said Hahn.
Dr. Anthony Fauci, the nation’s top infectious disease expert and the director of the National Institute of Allergy and Infectious Diseases, praised the drug Wednesday. He said preliminary results from an NIH study found 1,063 patients tested with Remdesivir took 11 days to recover versus 15 days for others.
“The data shows that remdesivir has a clear-cut significant positive effect in diminishing the time to recovery,” he said during a White House press conference on Wednesday.
Gilead has said it would donate its available stock of the drug and is ramping up production to make more.
“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,” company CEO Daniel O’Day said in an open letter sent out earlier this week. “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 FDA normally requires evidence of a drug’s effectiveness after rigorously-controlled patient studies before it can be brought to market. In the case of health emergencies, the agency can waive certain standards id the drugs potential benefits outweigh the risks.
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No drugs are approved now for treating the coronavirus, and remdesivir will still need formal approval.
The FDA previously approved emergency use authorization to malaria drug hydroxychloroquine after it was touted by Trump. No evidence exists that it works as a treat for COVID-19 paitients.
The Associated Press contributed to this report.
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