Veklury FDA Approval History

Reviewed by Judith Stewart, BPharm. Last updated on Oct 22, 2020.

FDA Approved: Yes (First approved October 22, 2020)
Brand name: Veklury
Generic name: remdesivir
Dosage form: Injection
Company: Gilead Sciences, Inc.
Treatment for: COVID-19

Veklury (remdesivir) is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor indicated for the treatment of COVID-19 patients who require hospitalization.

• Veklury (remdesivir) was approved by the FDA on October 22, 2020.
• Veklury is indicated for the treatment of hospitalized COVID-19 patients who are 12 years of age and older, and who weigh at least 40 kg.
• Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.
• Remdesivir has broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens, including Ebola, SARS, Marburg, MERS and SARS-CoV-2, the virus that causes COVID-19.
• On August 7, 2020, Gilead submitted a new drug application (NDA) for Veklury (remdesivir).
• On August 28, 2020, it was announced that the FDA expanded the Emergency Use Authorization (EUA) for remdesivir to include treatment of all hospitalized patients with COVID-19. The previous EUA included the treatment of patients hospitalized with severe COVID-19. The expanded EUA was based on results from the Phase 3 SIMPLE trial evaluating remdesivir in hospitalized patients with moderate COVID-19, as well as results from the ACTT-1 trial in hospitalized patients with a range of disease severity.
• Final results from the double-blind, placebo-controlled, Phase 3 ACTT-1 trial demonstrated that patients receiving remdesivir achieved clinical recovery five days faster than those receiving placebo (10 days versus 15 days), and in patients who required oxygen support, those receiving remdesivir achieved clinical recovery seven days faster than those receiving placebo (11 days versus 18 days).
• Remdesivir is administered by intravenous infusion over a period of 30–120 minutes once daily for 5 days, with a maximum total treatment duration of 10 days if there is no clinical improvement.¹
• There are limited clinical data available for remdesivir. Adverse reactions reported in clinical trials include hypersensitivity reactions (including infusion-related and anaphylactic reactions), and elevated liver transaminases.