The US Food and Drug Administration plans to announce an emergency-use authorization for remdesivir, according to the New York Times.
The authorization for the investigational coronavirus treatment could come as soon as Wednesday, the Times reported, citing a senior administration official.
In a statement to CNN, the FDA on Wednesday said it is in discussions with Gilead Sciences, the maker of remdesivir, about making the drug available to 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,” said Michael Felberbaum, an FDA spokesperson.
The FDA’s expected move comes after Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Disease, announced encouraging results from a remdesivir trial in a White House meeting with President Trump. When compared to patients who received a placebo, remdesivir was shown to shorten the duration of Covid-19, but there was no statistically-significant difference in whether patients died. The full study has not yet been released, and the research has not been peer-reviewed.
An emergency-use authorization would be notable because remdesivir is not currently approved to treat any disease – unlike some other drugs that have been used for coronavirus patients, such as hydroxychloroquine.