BRIEF—FDA defends safety and efficacy of Veklury as COVID-1 therapy

Randomized, controlled trials are the gold standard for evaluating the safety and effectiveness of drugs, said the US Food and Drug Administration yesterday, in a defense of its recent approval of a COVID-19 treatment, the efficacy of which has been questioned by the World Health Organization (WHO).

FDA’s approval of remdesivir, developed by Gilead Sciences and marketed as 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. The most compelling evidence of effectiveness was provided by the NIAID-sponsored ACTT-1 trial, with its rigorous trial design.

Based on the findings of the ACTT-1 trial, benefit to patients for Veklury was demonstrated including a shorter time to recovery and better odds of clinical improvement. The SOLIDARITY results do not refute these findings of benefit to patients, the agency stressed.

Earlier this month, the WHO recommended against using Gilead’s Veklury for people with COVID-19, regardless of how severely ill they are, saying there is currently no evidence that it improves survival or the need for ventilation.