WASHINGTON (AP) – U.S. regulators will allow emergency use of the first drug that appears to help some coronavirus patients recover faster.
President Donald Trump announced the move Friday after preliminary results from a government-sponsored study showed that the drug remdesivir shortened the time to recovery for hospitalized COVID-19 patients.
The drug maker Gilead Sciences and the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the investigation antiviral remdesivir to treat COVID-19.
Under the EUA, both 5-day and 10-day treatment duration’s are suggested, based on the severity of disease.
The authorization is temporary and does not take the place of the formal new drug application submission, review and approval process.
“We are working to meet the needs of patients, their families and healthcare workers around the world with the greatest sense of urgency and responsibility.” Said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences.
Gilead Sciences said it would donate its currently available stock of the drug and is ramping up production to make more.
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