Veklury FDA Approval History
Last updated by Judith Stewart, BPharm on May 1, 2022.
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 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
| Date | Article |
|---|
| Sep 16, 2022 | WHO Expands Recommendation for Veklury® (Remdesivir) to Patients With Severe Disease in Latest Update to COVID-19 Guideline |
| Apr 25, 2022 | Approval Veklury (remdesivir) is First and Only Approved Treatment for Pediatric Patients Under 12 Years of Age with COVID-19 |
| Apr 24, 2022 | Several New Studies Presented at ECCMID 2022 Confirm Veklury (Remdesivir) Activity in Treating COVID-19 |
| Feb 11, 2022 | Veklury (remdesivir) Retains Antiviral Activity Against Omicron, Delta and Other Emergent SARS-CoV-2 Variants in Multiple In Vitro Studies |
| Jan 21, 2022 | Approval FDA Approves Veklury (remdesivir) for the Treatment of Non-Hospitalized Patients at High Risk for COVID-19 Disease Progression |
| Sep 22, 2021 | Veklury (remdesivir) Significantly Reduced Risk of Hospitalization in High-Risk Patients with COVID-19 |
| Nov 25, 2020 | FDA: Remdesivir (Veklury) Approval for the Treatment of COVID-19 - The Evidence for Safety and Efficacy |
| Nov 19, 2020 | Baricitinib and Remdesivir Combination Receives Emergency Use Authorization from the FDA for the Treatment of Hospitalized Patients with COVID-19 |
| Oct 22, 2020 | An Open Letter from Merdad Parsey, Chief Medical Officer, Gilead Sciences |
| Oct 22, 2020 | Approval FDA Approves Veklury (remdesivir) for the Treatment of COVID-19 |
| Oct 15, 2020 | Gilead Sciences Statement on the Solidarity Trial |
| Oct 8, 2020 | NIH Clinical Trial Testing Hyperimmune Intravenous Immunoglobulin Plus Remdesivir to Treat COVID-19 Begins |
| Oct 8, 2020 | Final 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, 2020 | Gilead Sciences Update on Supply and Distribution of Veklury (remdesivir) in the United States |
| Aug 28, 2020 | Gilead’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, 2020 | Gilead Submits New Drug Application to U.S. Food and Drug Administration for Veklury (remdesivir) for the Treatment of COVID-19 |
| Aug 6, 2020 | Gilead Sciences Update on Veklury® (Remdesivir) Manufacturing Network |
| Aug 5, 2020 | Gilead Sciences Statement on State Attorneys General Letter on Remdesivir |
| Jul 10, 2020 | Gilead Presents Additional Data on Investigational Antiviral Remdesivir for the Treatment of COVID-19 |
| Jul 8, 2020 | Gilead Sciences Statement on the Initiation of Clinical Testing of an Inhaled Solution of Remdesivir for Potential Outpatient Treatment of COVID-19 |
| Jun 17, 2020 | Gilead Sciences Statement on Phase 2/3 Clinical Trial of Remdesivir in Pediatric Patients Hospitalized With COVID-19 |
| Jun 1, 2020 | Gilead Announces Results From Phase 3 Trial of Remdesivir in Patients With Moderate COVID-19 |
| May 27, 2020 | Genentech Initiates Phase III Clinical Trial of Actemra Plus Remdesivir in Hospitalized Patients With Severe COVID-19 Pneumonia |
| May 7, 2020 | Gilead Announces Approval of Veklury® (remdesivir) in Japan for Patients With Severe COVID-19 |
| May 1, 2020 | Gilead’s Investigational Antiviral Remdesivir Receives U.S. Food and Drug Administration Emergency Use Authorization for the Treatment of COVID-19 |
| Apr 29, 2020 | Gilead Announces Results From Phase 3 Trial of Investigational Antiviral Remdesivir in Patients With Severe COVID-19 |
| Apr 29, 2020 | Gilead Sciences Statement on Positive Data Emerging From National Institute of Allergy and Infectious Diseases’ Study of Investigational Antiviral Remdesivir for COVID-19 |
| Apr 10, 2020 | Data on 53 Patients Treated With Investigational Antiviral Remdesivir Through the Compassionate Use Program Published in New England Journal of Medicine |
| Mar 25, 2020 | Gilead Sciences Statement on Request to Rescind Remdesivir Orphan Drug Designation |
| Mar 22, 2020 | Gilead Sciences Statement on Access to Remdesivir Outside of Clinical Trials |
| Feb 26, 2020 | Gilead Sciences Initiates Two Phase 3 Studies of Investigational Antiviral Remdesivir for the Treatment of COVID-19 |
| Jan 31, 2020 | Gilead Sciences Statement on the Company’s Ongoing Response to the 2019 Novel Coronavirus (2019-nCoV) |
Further information
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