FDA grants full approval to remdesivir days after WHO Solidarity finds no mortality benefit
The FDA approved Gilead's Veklury (remdesivir) as the first fully approved COVID-19 treatment, for hospitalized patients 12 and older, citing three randomized trials including ACTT-1, which showed faster recovery. The decision landed one week after the WHO's Solidarity trial — an open-label trial of ~11,300 patients in 30 countries, preprinted Oct. 15 and later published in NEJM — reported remdesivir had little or no effect on mortality, ventilation, or hospital stay. Gilead and some researchers questioned Solidarity's open-label, no-placebo design; the FDA's approval rested on the placebo-controlled ACTT-1.
Primary quotes
“Today's approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic.”
FDA Commissioner Stephen Hahn
“These remdesivir, hydroxychloroquine, lopinavir, and interferon regimens had little or no effect on hospitalized patients with Covid-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay.”
WHO Solidarity Trial Consortium, NEJM
Linked sources
Related contentions
Unresolved. The efficacy question for ivermectin in COVID-19 is largely settled against benefit in the major RCTs, but the dispute over the tone and legality of the FDA's messaging — and over whether early dismissal distorted research and prescribing — remains contested in court (Apter v. HHS, revived by the Fifth Circuit in 2023 and later settled with the FDA removing the posts) and in public debate.