Source: China State Council Information Office
The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for an experimental anti-viral drug remdesivir to treat COVID-19, according to the agency on Friday.
In an FDA fact sheet for patients and their families and caregivers, the agency noted that remdesivir has not undergone the same type of review as an FDA-approved or cleared product.
Remdesivir is an investigational antiviral medicine to treat certain people in the hospital with COVID-19, said the FDA, adding the drug is still being studied.
“There is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19,” said the FDA.
Remdesivir was shown in a clinical trial to shorten the time to recovery in some people.
There are no medicines approved by the FDA as safe and effective to treat people in the hospital who have COVID-19. Therefore, the FDA has authorized the emergency use of remdesivir for the treatment of COVID-19 under an EUA, said the agency.
Remdesivir is given to patients through a vein one time each day for up to 10 days depending on recommendations of healthcare providers, according to the FDA. The drug may help decrease the amount of the coronavirus in bodies and help patients get better faster, said the agency.
Possible side effects of remdesivir include infusion-related reactions and increases in levels of liver enzymes, according to the FDA.
“These are not all the possible side effects of remdesivir. Remdesivir is still being studied so it is possible that all of the risks are not known at this time,” said the FDA.
Remdesivir, developed by American biopharmaceutical company Gilead Sciences, is an investigational broad-spectrum antiviral treatment administered via daily infusion for 10 days.
It is not yet licensed or approved anywhere globally while multiple Phase 3 studies are ongoing to determine the safety and efficacy of the drug for the treatment of COVID-19.
Data from a clinical trial suggested antiviral drug remdesivir showed “quite good news” and sets a new standard of care for COVID-19 patients, said Anthony Fauci, director of the National Institute of Allergy and Infectious Disease (NIAID), earlier this week.
Fauci said the median time of recovery for patients taking the drug was 11 days, compared to 15 days in the placebo group.
According to a release of the NIAID, hospitalized patients with advanced COVID-19 and lung involvement who received remdesivir recovered faster than similar patients who received placebo.