The U.S. Food and Drug Administration (FDA) has approved the antiviral drug remdesivir (Veklury) for the treatment of patients with COVID-19 requiring hospitalization. As an antiviral drug, Remdesivir works to stop replication of SARS-CoV-2, the virus that causes COVID-19. Previously authorized by the FDA for emergency use to treat COVID-19, remdesivir is now the first and only approved COVID-19 treatment in the United States. The drug is now widely available in hospitals across the country, following early investments to rapidly expand manufacturing capacity to increase supply.
In the United States, Remdesivir is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. Remdesivir should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.
This approval is based on three randomized controlled trials including the recently published, final results of the National Institute of Allergy and Infectious Diseases’ (NIAID) double blind, placebo-controlled Phase 3 ACTT-1 trial, which showed that treatment with remdesivir resulted in clinically meaningful improvements across multiple outcome assessments compared with placebo in hospitalized patients with COVID-19. Based on the strength of these data, remdesivir has become a standard of care for the treatment of COVID-19 in hospitalized patients.
Remdesivir is a nucleotide analog invented by Gilead, building on more than a decade of the company’s antiviral research. Remdesivir has broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens, including Ebola, SARS, Marburg, MERS and SARS-CoV-2, the virus that causes COVID-19.
Remdesivir has been approved or authorized for temporary use as a COVID-19 treatment in approximately 50 countries worldwide.
*The information above is from Gilead Sciences. Inc. (manufacturer), https://www.gilead.com/Leave a reply