Veklury FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 27, 2021.
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
| Date | Article |
|---|
| 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) |
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