Skip To Content

FDA approves first COVID-19 treatment for intravenous (IV) use in hospitals or other controlled clinical settings

October 26, 2020 · Clinical Team

Veklury® (remdesivir) is the first medication to be approved for the treatment of coronavirus disease 2019 (COVID-19) by the U.S. Food and Drug Administration (FDA) on October 22, 2020.

Marketed by Gilead Sciences, Inc., Veklury is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor indicated for adults and pediatric patients (12 years of age and older and weighing at least 88 pounds) for the treatment of COVID-19 requiring hospitalization.

Remdesivir should only be administered via IV infusion for up to ten days in a hospital or controlled clinical setting, meaning under medical supervision in a healthcare setting capable of providing acute care. It is not indicated or commercially available for at-home use. For more detailed information on Veklury, please click here.

Although remdesivir was originally authorized for use under an Emergency Use Authorization (EUA) on May 1, 2020, this FDA-approval does not include the entire population under the EUA, which has been revised. According to the FDA, this approval was based on an analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19.

Impact on workers’ compensation and auto no-fault  

Because Veklury is an injection indicated for IV infusion and not for use as a take-home prescription, we do not expect this antiviral medication to be dispensed at a retail or home delivery pharmacy for any claimants. Therefore, there is no impact on our standard formularies.    

If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.

View other posts on our Clinical Connection blog.

 

Sources:
1. U.S. Food and Drug Administration (FDA). News & Events. Newsroom. Press Announcements. FDA News Release. FDA Approves First Treatment for COVID-19. October 22, 2020. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19.
2. Veklury® [package insert]. Foster City, CA: Gilead Sciences, Inc.; October 2020.

Subscribe today to receive our latest blogs, articles and more.