FDA Approves Veklury® (remdesivir) for the Treatment of Non-hospitalized patients

The FDA has approved an expanded use of Veklury to treat non-hospitalized patients who are at high risk of progression to severe COVID-19, including hospitalization or death. We are encouraged by the FDA’s decision as Veklury can now help even more patients recover faster and reduce the likelihood of disease progression. 

The indication is based on results from the PINETREE study, a Phase 3, randomized, double-blind, placebo-controlled trial that showed Veklury reduced the risk of hospitalization by 87% in patients at high risk of progression to severe COVID-19. The study was presented at IDWeek in October and published in the New England Journal of Medicine in December.