FDA Approves Remdesivir for Hospitalized Patients

FDA announced on Oct. 22, 2020 the approval of Gilead’s antiviral drug Veklury (remdesivir) as the first treatment for patients with COVID-19 that require hospitalization. The approval was designated for adult and pediatric patients 12 years of age and older, weighing at least 40 kilograms (88 pounds) and must be administered in a hospital or in a healthcare setting that provides acute care comparable to inpatient hospital care.

The agency also issued a new Emergency Use Authorization for Veklury for hospitalized pediatric patients under 12 years of age weighing at least 3.5 kg or hospitalized pediatric patients weighing 3.5 kg to less than 40 kg with suspected or laboratory confirmed COVID-19 for whom use of an intravenous agent is clinically appropriate. Clinical trials to assess the safety and efficacy for the pediatric patient group are ongoing.

In announcing the approval, FDA noted that the decision was based on analysis of three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19.

In one study, the median time to recovery from COVID-19 was 10 days for the Veklury group compared to 15 days for the placebo group. The odds of clinical improvement at Day 15 were also statistically significantly higher in the Veklury group when compared to the placebo group, FDA reported.

A second trial showed the odds of a subject’s COVID-19 symptoms improving were statistically significantly higher at day 11 for a five-day Veklury treatment group when compared to those receiving only standard of care. For patients in a 10-day treatment group, odds of symptom improvement when compared to those receiving only standard of care were numerically favorable, but not statistically significantly different, FDA reported.

A third trial of hospitalized adults with severe COVID-19 compared treatment with Veklury for five days and treatment with Veklury for 10 days, with clinical status evaluated on day 14. The study found the odds of a subject’s symptoms improving were similar for those in the five-day Veklury group as those in the 10-day Veklury group; there were no statistically significant differences in recovery rates or mortality rates between the two groups, FDA reported.

FDA granted Veklury Fast Track and Priority Review designations and a Material Threat Medical Countermeasure Priority Review Voucher.

Sources: FDA and Gilead​