USA – FDA authorizes Gilead’s remdesivir for emergency use

The US Food and Drug Administration (FDA) on Friday issued an emergency use authorization (EUA) allowing the use of Gilead Sciences’ remdesivir to treat hospitalized patients with severe cases of coronavirus disease (COVID-19).
 
The EUA comes just two days after the National Institutes of Health (NIH) announced preliminary results from a randomized trial that found patients treated with remdesivir had a 31% shorter time to recovery than patients taking a placebo.
 
Results from other studies of remdesivir have been mixed. In a Chinese study published the same day in The Lancet, researchers were unable to identify a statistically significant clinical benefit, though that study was halted early due to recruitment issues. Another unpublished US study comparing 5- and 10-day dosing regimens found patients in both arms of the study had similar improvement in clinical status.
 
“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 FDA Commissioner Stephen Hahn