US allows use of experimental drug to aid in virus recovery

WASHINGTON — U.S. 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 237,000 people worldwide.

The FDA said that Gilead Science’s intravenous drug would be specifically indicated for hospitalized patients with “severe disease,” such as those experiencing breathing problems requiring supplemental oxygen or ventilators.

The FDA acted after preliminary results from a government-sponsored study showed that remdesivir shortened the time to recovery by 31% 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 were able to leave the hospital in 11 days on average versus 15 days for the comparison group.

The FDA said that performance warranted Friday’s

decision, though regulators acknowledged “there is limited information known about the safety and effectiveness of using remdesivir.”

The drug’s side effects include potential inflammation of the liver and problems related to its infusion, which could lead to nausea, vomiting, sweating and low blood pressure.

The National Institutes of Health’s Dr. Anthony Fauci said this week the drug would become a new standard of care for severely ill COVID-19 patients.