FDA says WHO study does not refute efficacy of Veklury for COVID-19

FDA on Wednesday made public the review that led to approval of Gilead’s Veklury remdesivir for treatment of hospitalized COVID-19 patients, and explained why it believes the WHO-sponsored SOLIDARITY trial that failed to demonstrate a benefit from Veklury does not refute results from an NIH trial that demonstrated an acceleration in recovery among hospitalized patients who received the drug.

On Nov. 19, the WHO issued a “weak or conditional recommendation against” treating hospitalized COVID-19 patients with Veklury, citing data from the SOLIDARITY master protocol trial in which the drug did not reduce 28-day mortality, initiation of ventilation or duration of hospitalization. ...