Medical workers carry a patient from an ambulance to George Washington University Hospital in Washington D.C., the United States, on April 27, 2020. (TING SHEN / XINHUA)
WASHINGTON - The US 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 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.
Remdesivir 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
Remdesivir, which previously failed as a treatment for Ebola, is being tried against COVID-19 because it is designed to disable the mechanism by which certain viruses, including the new coronavirus, make copies of themselves and potentially overwhelm their host’s immune system.
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.
With many countries reeling from the coronavirus pandemic, interest in the drug has been high because there are currently no approved treatments or preventive vaccines for COVID-19. Doctors are desperate for anything that might alter the course of the disease that attacks the lungs and can shut down other organs in extremely severe cases.
“It’s the first authorized therapy for COVID-19, so we’re really proud to be part of it,” FDA Commissioner Stephen Hahn said during the meeting.
Remdesivir, developed by American biopharmaceutical company Gilead Sciences, was previously available only for patients enrolled in clinical trials or for patients cleared to get the drug under expanded use and compassionate use programs.
The drug 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.
A draft study abstract released inadvertently by the World Health Organization (WHO) last week said remdesivir failed to improve patients’ condition or reduce the pathogen’s presence in the bloodstream. The drugmaker said the findings were inconclusive because the study was terminated early.
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