Gilead announces FDA approval of Veklury sNDA

Gilead Sciences announced that the FDA approved a supplemental new drug application, or sNDA, for the use of Veklury in COVID-19 patients with severe renal impairment, including those on dialysis. With this approval, Veklury is now the first and only approved antiviral COVID-19 treatment that can be used across all stages of renal disease. More than 1 in 7 people in the U.S. are estimated to have chronic kidney disease, or CKD, and are at increased risk of COVID-19 related morbidity and mortality. The U.S. approval comes on the heels of the European Commission decision to extend the approved use of Veklury to treat COVID-19 in people with severe renal impairment, including those on dialysis, which was adopted on June 26.