FDA approves remdesivir as first treatment for COVID-19
The U.S. Food and Drug Administration (FDA) announced Thursday the approval of the antiviral drug Veklury, also known as remdesivir, for the treatment of the novel coronavirus (COVID-19) requiring hospitalization. It is the first treatment for COVID-19 to receive FDA approval.
The drug is approved for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms. The FDA said the treatment should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.
This approval does not include the entire population that had been authorized to use remdesivir under an Emergency Use Authorization (EUA) originally issued on May 1, 2020. To ensure continued access to the pediatric population previously covered under the EUA, the FDA revised the EUA for remdesivir to authorize the drug’s use for treatment of suspected or laboratory confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kilograms to less than 40 kilograms or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg. Clinical trials assessing the safety and efficacy of remdesivir in this pediatric patient population are ongoing, the agency said.
The news comes a week after pre-publication of an international trial led by the World Health Organization (WHO), which criticized the efficacy of remdesivir in improving recovery time and survival.
According to the FDA, the approval of remdesivir was supported by analysis of data from three randomized controlled clinical trials that included patients hospitalized with mild to severe COVID-19.