US FDA approves emergency use of remdesivir for COVID-19 patients
Washington: The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the experimental anti-viral drug remdesivir to treat COVID-19.
In an FDA fact sheet for patients and their families and caregivers, the agency on Friday noted that remdesivir has not undergone the same type of review as an FDA-approved or cleared product, reports Xinhua news agency.
Remdesivir is an investigational antiviral medicine to treat certain people in the hospital with COVID-19, said the FDA, adding the drug was 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.