Gilead Sciences files NDA at FDA Veklury, an investigational antiviral for the treatment of patients with COVID-19.

Gilead Sciences, Inc. announced that it has submitted a New Drug Application (NDA) to the FDA for Veklury (remdesivir), an investigational antiviral for the treatment of patients with COVID-19. Veklury is currently available in the U.S. under an Emergency Use Authorization for the treatment of hospitalized patients with severe COVID-19. The filing is the final tier of the rolling NDA submission that was initiated on April 8, 2020. The filing is supported by data from two randomized, open-label, multi-center Phase III clinical studies of Veklury conducted by Gilead and the Phase III randomized, placebo-controlled study of Veklury conducted by the National Institute of Allergy and Infectious Diseases (NIAID). These studies demonstrated that treatment with Veklury led to faster time to recovery compared with placebo and that a 5-day or 10-day treatment duration led to similar clinical improvement. Across studies, Veklury was generally well-tolerated in both the 5-day and 10-day treatment groups, with no new safety signals identified.