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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.
1. US Food and Drug Administration. Fact sheet for health care providers: Emergency use authorization (EUA) of Veklury (remdesivir). Revised 2020 Aug. From FDA website. https://www.fda.gov/media/137566/download

Development Timeline for Veklury

DateArticle
Nov 25, 2020FDA: Remdesivir (Veklury) Approval for the Treatment of COVID-19 - The Evidence for Safety and Efficacy
Nov 19, 2020Baricitinib and Remdesivir Combination Receives Emergency Use Authorization from the FDA for the Treatment of Hospitalized Patients with COVID-19
Oct 22, 2020An Open Letter from Merdad Parsey, Chief Medical Officer, Gilead Sciences
Oct 22, 2020Approval FDA Approves Veklury (remdesivir) for the Treatment of COVID-19
Oct 15, 2020Gilead Sciences Statement on the Solidarity Trial
Oct  8, 2020NIH Clinical Trial Testing Hyperimmune Intravenous Immunoglobulin Plus Remdesivir to Treat COVID-19 Begins
Oct  8, 2020Final Results of National Institute of Allergy and Infectious Diseases’ ACTT-1 Trial Published in New England Journal of Medicine Expand Clinical Benefits of Veklury® (remdesivir) for the Treatment of COVID-19
Oct  1, 2020Gilead Sciences Update on Supply and Distribution of Veklury (remdesivir) in the United States
Aug 28, 2020Gilead’s Investigational Antiviral Veklury (Remdesivir) Receives U.S. Food and Drug Administration Emergency Use Authorization for the Treatment of Patients With Moderate COVID-19
Aug 10, 2020Gilead Submits New Drug Application to U.S. Food and Drug Administration for Veklury (remdesivir) for the Treatment of COVID-19
Aug  6, 2020Gilead Sciences Update on Veklury® (Remdesivir) Manufacturing Network
Aug  5, 2020Gilead Sciences Statement on State Attorneys General Letter on Remdesivir
Jul 10, 2020Gilead Presents Additional Data on Investigational Antiviral Remdesivir for the Treatment of COVID-19
Jul  8, 2020Gilead Sciences Statement on the Initiation of Clinical Testing of an Inhaled Solution of Remdesivir for Potential Outpatient Treatment of COVID-19
Jun 17, 2020Gilead Sciences Statement on Phase 2/3 Clinical Trial of Remdesivir in Pediatric Patients Hospitalized With COVID-19
Jun  1, 2020Gilead Announces Results From Phase 3 Trial of Remdesivir in Patients With Moderate COVID-19
May 27, 2020Genentech Initiates Phase III Clinical Trial of Actemra Plus Remdesivir in Hospitalized Patients With Severe COVID-19 Pneumonia
May  7, 2020Gilead Announces Approval of Veklury® (remdesivir) in Japan for Patients With Severe COVID-19
May  1, 2020Gilead’s Investigational Antiviral Remdesivir Receives U.S. Food and Drug Administration Emergency Use Authorization for the Treatment of COVID-19
Apr 29, 2020Gilead Announces Results From Phase 3 Trial of Investigational Antiviral Remdesivir in Patients With Severe COVID-19
Apr 29, 2020Gilead Sciences Statement on Positive Data Emerging From National Institute of Allergy and Infectious Diseases’ Study of Investigational Antiviral Remdesivir for COVID-19
Apr 10, 2020Data on 53 Patients Treated With Investigational Antiviral Remdesivir Through the Compassionate Use Program Published in New England Journal of Medicine
Mar 25, 2020Gilead Sciences Statement on Request to Rescind Remdesivir Orphan Drug Designation
Mar 22, 2020Gilead Sciences Statement on Access to Remdesivir Outside of Clinical Trials
Feb 26, 2020Gilead Sciences Initiates Two Phase 3 Studies of Investigational Antiviral Remdesivir for the Treatment of COVID-19
Jan 31, 2020Gilead Sciences Statement on the Company’s Ongoing Response to the 2019 Novel Coronavirus (2019-nCoV)

Further information

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