Spotlight on CDER Science
Remdesivir (Veklury) Approval for the Treatment of COVID-19—The Evidence for Safety and Efficacy
Under FDA law, approval of a new drug requires substantial evidence of effectiveness and a demonstration of safety for the drug’s intended use(s). The approval of remdesivir (Veklury) for the treatment of patients hospitalized with COVID-19 met this legal and scientific standard.
Background
Randomized, controlled trials are the gold standard for evaluating the safety and effectiveness of drugs. FDA’s approval of remdesivir (Veklury) was supported by the agency’s independent, in-depth analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19. This included the ACTT-1 trial sponsored by National Institute of Allergy and Infectious Disease (NIAID) and the “SIMPLE” trials (GS-US-540-5774 and GS-US-540-5773) sponsored by Gilead Sciences Inc. The most compelling evidence of effectiveness was provided by the NIAID-sponsored ACTT-1 trial, with its rigorous trial design.