US FDA broadens EUA for Veklury (remdesivir) to treat all hospitalised COVID-19 patients
The expansion is supported by the FDA’s analysis of additional data from two randomised, controlled clinical trials that included patients with mild or moderate disease
The US Food and Drug Administration broadened the scope of the existing emergency use authorisation (EUA) for the drug Veklury (remdesivir) to include treatment of all hospitalised adult and paediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of the disease.
In May 2020, the FDA issued a EUA that authorised Veklury for the treatment of hospitalised adult and pediatric patients with severe COVID-19. The emergency use of Veklury was limited to those patients with severe disease, which was defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator.
Under the law, the FDA may revise an emergency use authorisation, as appropriate, based on additional public health considerations, such as new data. The expansion of the scope of the EUA to include hospitalised patients with mild or moderate COVID-19 is supported by the FDA’s analysis of additional data from two randomised, controlled clinical trials that included patients with mild or moderate disease.
One randomised, double-blind, placebo-controlled clinical trial (ACTT-1), conducted by the National Institute of Allergy and Infectious Diseases, evaluated how long it took for subjects to recover from COVID-19 within 29 days of being treated. The trial looked at 1,062 hospitalised subjects with mild, moderate and severe COVID-19 who received Veklury (n=541) or placebo (n=521), plus standard of care. Recovery was defined as either being discharged from the hospital or being hospitalised but not requiring supplemental oxygen and no longer requiring ongoing medical care. The median time to recovery from COVID-19 was 10 days for the Veklury group compared to 15 days for the placebo group, a statistically significant difference. Overall, the odds of clinical improvement at Day 15 were also statistically significantly higher in the Veklury group when compared to the placebo group. In hospitalised patients with mild to moderate disease, the results for time to recovery as well as the odds of improvement at Day 15 numerically favoured the Veklury group and were consistent with the overall study results.
A separate randomised, open-label multi-centre clinical trial (Study GS-US-540-5774) of hospitalised adult subjects with moderate COVID-19 compared treatment with Veklury for five days (n=191) and treatment with Veklury for 10 days (n=193) with standard of care (n=200). Researchers evaluated the clinical status of subjects on Day 11. Overall, the odds of a subject’s COVID-19 symptoms improving were statistically significantly higher in the five-day Veklury group at Day 11 when compared to those receiving only standard of care. The odds of improvement with the 10-day treatment group when compared to those receiving only standard of care were numerically favourable, but not statistically significantly different. At Day 28, mortality was less than or equal to two per cent in all treatment groups. Limitations of this trial included the open-label design.