FDA expands emergency use authorization for remdesivir


Gilead Sciences manufactures remdesivir under the name Veklury. File Photo by Terry Schmitt/UPI | License Photo

Aug. 28 (UPI) -- The Food and Drug Administration on Friday expanded its emergency use authorization for antiviral remdesivir to allow it to be used on all hospitalized patients.

The FDA's previous EUA in May allowed doctors to use the drug on only hospitalized adult and pediatric patients with "severe" COVID-19. Now, all hospitalized patients with suspected or laboratory confirmed coronavirus may receive the drug regardless of the severity of the disease

"The FDA continues to make safe and potentially helpful treatments for COVID-19 available as quickly as possible in order to help patients," FDA Commissioner Stephen Hahn said. "The data to support today's action are encouraging. The data show that this treatment has the potential to help even more hospitalized patients who are suffering from the effects of this devastating virus."

Clinic results on the antiviral have been mixed, with one study last week showing the drug doesn't improve outcomes in people hospitalized with moderate pneumonia caused by COVID-19.

RELATED Study: Targeting COVID-19 virus reproduction could halt infections

But research published in May suggested the drug might be effective in people with severe COVID-19.

A study published by the New England Journal of Medicine found that seriously ill patients infected with the new coronavirus had an average recovery time of 11 days after receiving the drug, compared to 15 days for those given a placebo.

Originally developed to treat Ebola virus, remdesivir works by slowing the production of enzymes that play a key role in the replication of viruses, including coronaviruses, according to Gilead Sciences.

RELATED COVID-19 clinical trials lack diversity, researchers say


Gilead manufactures remdesivir under the brand name Veklury.

"As we learn more about COVID-19 and we further establish the efficacy and safety profile of Veklury, we see benefit to making the drug available to patients at earlier stages of the disease," said Merdad Parsey, chief medical officer at Gilead Sciences.

"Today's action by the FDA enables physicians to consider a broader range of eligible patients to potentially receive Veklury."