Remdesivir injection is used to treat coronavirus disease 2019 (COVID-19) in hospitalized patients. It is also used to treat mild to moderate COVID-19 in non-hospitalized patients who are at high risk for progression to severe COVID-19 (e.g., hospitalization, death). Remdesivir is an antiviral medicine that works on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Today the U.S. Food and Drug Administration approved for Covid-19 drug remdesivir to treat infants and children for 28 days. The Agency said that the FDA’s decision makes the drug first approved Covid-19 treatment for children under 12. Previously remdesivir was approved to treat Covid-19 for adults only. The drug made by Gilead Sciences and sold as remdesivir had been approved to treat adults and patients 12 and older who weighed at least 88 pounds. It is given as an injection.
Dr. Patrizia Cavazzoni, M.D., Director of FDA’s Center for Drug Evaluation and Research, said in a news release, “As Covid 19 can lead to severe illness in kids, a some of whom do not presently have vaccination option, there continues to be a need for secure and effective Covid-19 treatment options for this population. “Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s responsibility to that need.”
Dr. Daniel Griffin is an instructor in clinical medicine and associate research scientist in the Biochemistry and Molecular Biophysics department at Columbia University. He said The FDA’s approval of remdesivir for young children is “great.” Griffen called remdesivir a “very effective antiviral” at preventing the progression of Covis-19 to a more severe illness, lowering the risk of hospitalization or death when given early in the course of Covid-19 infection.
More recently, the results have come out truly remarkable research published in the New England Journal of Medicine showing that taking remdesivir in the first five days of the acute viral phase, before the door closes, can prevent progression by about 90%. In that study, it was 87 percent. So, if you give it to the right patient at the right time, remdesivir can be an extremely successful antiviral,” Griffin said Monday. Suppose we can expand this to youngsters and deliver it to them at the vital moment when it can make the most difference. In that case, we are opening up many possibilities because these kids don’t have a lot of options,’ he added. “They don’t have access to some of the other therapies that are only available to people over the age of 12.”
Remdesivir is an adenosine analog nucleotide prodrug. It binds to the viral RNA polymerase and prevents viral replication by prematurely stopping RNA transcription. Remdesivir has been shown to be effective against SARS-CoV-2 in vitro. 1 Remdesivir treatment was started immediately after inoculation in a rhesus macaque model of SARS-CoV-2 infection; the remdesivir-treated animals had lower viral levels in the lungs and minor lung damage than the control animals. 2 Remdesivir is predicted to be effective against the B.1.1.529 (Omicron) strain under investigation.
