Gilead’s Veklury (remdesivir) was the first treatment to gain full approval for COVID-19 treatment. It is an antiviral drug used for the treatment of hospitalized COVID-19 patients in the US, and has been rapidly adopted as the global standard of care for moderate and severe patients since its initial US Emergency Use Authorization in May 2020 (full approval occurred in October 2020). Veklury’s rapid commercial success (sales totaled $5.6bn in 2021) has been driven by the results of the ACTT-1 study, which showed that the drug significantly reduced the duration of hospitalization compared to placebo in patients with moderate-severe COVID-19 pneumonia. However, a decline in sales has begun to occur, with full-year revenues for Veklury in 2022 of $3.9bn showing a 30% decrease compared to 2021. The company attributed this decline to changing COVID-19 infection rates and the severity of infections and hospitalizations, as well as the effectiveness of vaccination rollouts. During 2022, Veklury’s approval for use in COVID-19 treatment in the US was expanded to also cover patients in the outpatient setting, for use in non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19, while also covering the treatment of both hospitalized and non-hospitalized pediatric patients over 28 days old and weighing at least 3kg who are at high risk of progression to severe COVID-19. Previously, the World Health Organization (WHO) had recommended against Veklury’s use following disappointing results from the WHO-sponsored SOLIDARITY trial, which contradicted the positive findings in the ACTT-1 study; however, this recommendation has since been revised. As of April 2022, the WHO now recommends use of Veklury in mild or moderate COVID-19 patients who are at high risk of hospitalization. This change followed the release of results from Gilead’s Phase III PINETREE trial, which showed that a three-day course of Veklury treatment significantly reduced the risk of hospitalization for non-hospitalized patients at high risk of disease progression. 

This Datamonitor Healthcare report contains a Disease Analysis module.