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FDA Permits Emergency Use of Drug for COVID-19 Patients

Remdesivir might help shorten recovery time
By Newser Editors and Wire Services
Posted May 1, 2020 4:05 PM CDT

(Newser) – US regulators on Friday allowed emergency use of an experimental drug that appears to help some coronavirus patients recover faster. It is the first drug shown to help fight COVID-19, which has killed more than 230,000 people worldwide. President Trump announced the news at the White House alongside Food and Drug Administration Commissioner Stephen Hahn, who said the drug would be available for patients hospitalized with COVID-19, the AP reports. The FDA acted after preliminary results from a government-sponsored study showed that Gilead Sciences’s remdesivir shortened the time to recovery by 31%, or about four days on average, for hospitalized COVID-19 patients. The study of 1,063 patients is the largest and most strict test of the drug and included a comparison group that received just usual care so remdesivir's effects could be rigorously evaluated.

Those given the drug left the hospital in 11 days on average, versus 15 days for the comparison group. The drug also might be reducing deaths, though that’s not certain so far. Dr. Anthony Fauci said the drug would become a new standard of care for severely ill COVID-19 patients. The drug has not been tested on people with a milder illness, and it's currently given through an IV in a hospital. The FDA invoked its emergency powers to speed experimental drugs to patients. In normal times, the FDA requires "substantial evidence" of a drug’s safety and effectiveness, usually through one or more large patient studies. But during public health emergencies the agency can waive those standards, simply requiring that a drug’s potential benefits outweigh its risks. Gilead has said it would donate its current stock of the drug and is ramping up production. No drugs are approved now for treating the coronavirus, and remdesivir will still need formal approval.

(Read more remdesivir stories.)

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