The Food and Drug Administration (FDA) has issued a response stating that results from the World Health Organization-sponsored SOLIDARITY trial do not refute the clinical benefits of remdesivir in hospitalized patients with coronavirus disease 2019 (COVID-19).
On November 20, 2020, the WHO issued a conditional recommendation against the use of remdesivir in hospitalized COVID-19 patients. The recommendation was based on data from the open-label, randomized SOLIDARITY trial which suggested that remdesivir did not improve mortality, the need for mechanical ventilation, time to clinical improvement or other patient-important outcomes. The evidence was considered to be low or very low certainty for all outcomes with not enough data to support the use of remdesivir.
Despite these findings from the SOLIDARITY trial, the FDA approved remdesivir (Veklury; Gilead Sciences) in October 2020 based on three phase 3 trials (ACTT-1, SIMPLE-Severe, and SIMPLE-Moderate) demonstrating a highly statistically significant reduction in time to recovery and better odds of clinical improvement in hospitalized COVID-19 patients. While both the SOLIDARITY and the ACTT-1 trials did not find a statistically significant difference in mortality between remdesivir and standard of care, the FDA noted that the 2 clinical trials had different trial designs and primary end points.
The FDA concluded that “the design of ACTT-1 was better suited to rigorously assess a time to recovery end point compared to a trial with an open-label design, such as the SOLIDARITY trial.” Moreover, the FDA stated that the results from SOLIDARITY did not refute the findings from ACTT-1.
Remdesivir is currently marketed under the trade name Veklury and is approved for the treatment of COVID-19 in patients aged 12 years and older and weighing at least 40kg requiring hospitalization.
For more information visit fda.gov.
Remdesivir (Veklury) approval for the treatment of COVID-19—the evidence for safety and efficacy. [press release]. Silver Spring, MD: US Food and Drug Administration; November 25, 2020.