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Veklury FDA Approval History

Last updated by Judith Stewart, BPharm on July 18, 2023.

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.

  • Veklury is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (28 days of age and older and weighing at least 3 kg) with positive results of direct SARS-CoV-2 viral testing, who are:
    - hospitalized, or
    - not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.
  • Veklury contains remdesivir, a nucleotide analog antiviral which works to inhibit viral replication by targeting SARS-CoV-2 viral RNA polymerase.
  • Veklury is administered by intravenous infusion over 30 to 120 minutes.
  • Warnings and precautions associated with Veklury include hypersensitivity including infusion-related and anaphylactic reactions; increased risk of transaminase elevations; and risk of reduced antiviral activity when coadministered with chloroquine phosphate or hydroxychloroquine sulfate.
  • Common adverse reactions include nausea and increased liver enzymes (ALT and AST).

Development timeline for Veklury

DateArticle
Aug 24, 2023Approval FDA Approves Veklury (remdesivir) to Treat COVID-19 in People With Mild to Severe Hepatic Impairment With no Dose Adjustment
Jul 14, 2023Approval FDA Approves Veklury (remdesivir) for COVID-19 Treatment in Patients With Severe Renal Impairment, Including Those on Dialysis
Sep 16, 2022WHO Expands Recommendation for Veklury® (Remdesivir) to Patients With Severe Disease in Latest Update to COVID-19 Guideline
Apr 25, 2022Approval Veklury (remdesivir) is First and Only Approved Treatment for Pediatric Patients Under 12 Years of Age with COVID-19
Apr 24, 2022Several New Studies Presented at ECCMID 2022 Confirm Veklury (Remdesivir) Activity in Treating COVID-19
Feb 11, 2022Veklury (remdesivir) Retains Antiviral Activity Against Omicron, Delta and Other Emergent SARS-CoV-2 Variants in Multiple In Vitro Studies
Jan 21, 2022Approval FDA Approves Veklury (remdesivir) for the Treatment of Non-Hospitalized Patients at High Risk for COVID-19 Disease Progression
Sep 22, 2021Veklury (remdesivir) Significantly Reduced Risk of Hospitalization in High-Risk Patients with COVID-19
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)

See also

Veklury (remdesivir) Consumer information

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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