The US Food and Drug Administration has issued an emergency authorization for the drug remdesivir to be used in cases of COVID-19 where patients are “hospitalized with severe disease.” The FDA made the announcement Friday afternoon, saying that while there’s still limited information about the safety or effectiveness of the experimental drug, a clinical trial earlier this week showed a faster recovery time in some patients.
Remdesivir, an experimental antiviral drug produced by biotech firm Gilead Sciences, will be injected into suspected or confirmed coronavirus patients by health care providers where the patient has low blood oxygen levels, needs oxygen therapy or needs breathing support like a ventilator.
Health and Human Services Secretary Alex Azar called it “a significant step forward in battling COVID-19.”
The approval comes just two days after the drug showed “clear-cut positive effect” in a US trial. The US National Institute of Allergy and Infectious Diseases said Wednesday that preliminary data from a US-based clinical trial showed it can help patients recover from the coronavirus faster.
At that time, NIAID director Dr. Anthony Fauci said the early results were “a very important proof-of-concept because what it has proven is that a drug can block this virus.”
The NIAID trial involved 1,000 patients, showing a 31% faster recovery time, and a slightly lower mortality rate. Remdesivir was originally designed to treat Ebola, but was largely unsuccessful when trialled. A study in 2017 showed it to be effective against human coronaviruses.
Gilead said hospitals with ICUs and hospitals that the federal government decides most need the drug will be prioritized in receiving its limited supply of remdesivir. “Gilead is working with the US government on the logistics of remdesivir distribution and will provide more information when the company begins shipping the drug,” the company said Friday.
“We will continue to work with partners across the globe to increase our supply of remdesivir while advancing our ongoing clinical trials to supplement our understanding of the drug’s profile,” Daniel O’Day, CEO of Gilead Sciences, said in an emailed statement. “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.”