On October 22, 2020, the Food and Drug Administration (FDA) approved Veklury (remdesivir; Gilead Sciences Inc.) for the treatment of COVID-19.
Veklury is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor 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. Veklury should only be administered in a hospital or in a health care 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 Veklury under an Emergency Use Authorization (EUA) originally issued on May 1, 2020. In order to ensure continued access to the pediatric population previously covered under the EUA, the FDA revised the EUA for Veklury to authorize the drug’s use for treatment of suspected or laboratory confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg. Clinical trials assessing the safety and efficacy of Veklury in this pediatric patient population are ongoing.
The approval was supported by data from 3 randomized controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19.
Food and Drug Administration (FDA). FDA Approves First Treatment for COVID-19 [news release]. October 22, 2020. Available at: click here. Accessed October 22, 2020.