FDA Expands Emergency Use Authorization for Veklury (Remdesivir) to Include Hospitalized Patients with Moderate COVID-19
Aug 29, 2020 13:28
CST Updated
13:28
Gilead Sciences
Antiviral Drug Developer
FDA
U.S. Food and Drug Administration
National Institute of Allergy and Infectious Diseases
The National Institute of Allergy and Infectious Diseases (NIAID) is one of the 27 institutes and centers that constitute the National Institutes of Health (NIH), an agency within the U.S. Department of Health and Human Services. NIAID’s mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases. NIAID operates “intramural” laboratories in Maryland and Montana and funds research conducted by scientists at institutions across the United States and around the world.
August 29, 2020 /BioValleyBIOON/ -- Currently, the COVID-19 pandemic continues to spread rapidly worldwide. According to Baidu's "Real-time Epidemic Situation of Novel Coronavirus Pneumonia"Big DataReport, as of 12:00 on August 29, 2020, the global cumulativeOver 24.91 million confirmed cases, with over 841,000 deaths.
Remdesivir, an antiviral drug from Gilead Sciences, is a highly scrutinized potential therapeutic for COVID-19. In early May this year, the drug received U.S.FDAGranted Emergency Use Authorization (EUA) for the treatment of hospitalized patients with severe COVID-19. Furthermore, since May of this year,Remdesivir (Brand Name: Veklury®)It has been successively approved in multiple countries and regions worldwide (including the European Union and Japan) for the treatment of patients with COVID-19. In August this year, Gilead Sciences submitted a New Drug Application (NDA) for Veklury in the United States.
Recently, Gilead announced that the United StatesFDAVeklury has been granted Emergency Use Authorization (EUA) forTreatment of Patients with Moderate COVID-19.This EUA expands the previous authorization of Veklury, allowing the drug to be used forTreat all hospitalized patients with COVID-19, regardless of oxygen status.
This expanded EUA is based on the Phase 3 SIMPLE trial evaluating Veklury in patients with moderate COVID-19 pneumonia, and the ACTT-1 trial conducted by the National Institute of Allergy and Infectious Diseases (NIAID) evaluating Veklury in hospitalized patients with COVID-19 across a spectrum of disease severity.Clinical Trialresults.
The results of the Phase 3 SIMPLE study were published in the Journal of the American Medical Association (JAMA) on August 21, 2020, confirming the previously announced results from June 1, 2020. The primary endpoint was patient assessment on Day 11 using a 7-point ordinal scale.Patients randomized to receive 5 days of Veklury plus standard care were 65% more likely to show clinical improvement compared with those randomized to receive standard care alone (OR, 1.65; 95% CI: 1.09–2.48; p=0.017).For patients in the 10-day Veklury group, there was no statistically significant difference in clinical status improvement on day 11 compared with the standard-of-care group (OR, 1.31; 95% CI: 0.88–1.95; p=0.183).
Data published in JAMA indicate that Veklury was well tolerated in both the 5-day and 10-day treatment groups. In the 5-day, 10-day, and standard-of-care groups, the most commonAdverse ReactionsThe incidences were nausea (10% vs 9% vs 3%), diarrhea (6% vs 5% vs 7%), hypokalemia (5% vs 7% vs 2%), and headache (5% vs 5% vs 3%). The all-cause mortality rate on Day 28 was ≤2% in all treatment groups.
Dr. Merdad Parsey, Chief Medical Officer of Gilead Sciences, stated, “As awareness grows regarding the utility of Veklury in improving outcomes for a broad range of patients with COVID-19, we welcome the FDA’s decision to expand the Emergency Use Authorization (EUA). As our understanding of COVID-19 continues to evolve, we have further established the efficacy and safety profile of Veklury, and we have observed the benefits of administering the drug to patients in the early stages of the disease. Today,”FDAaction enables physicians to consider a broader range of eligible patients, providing them with the opportunity to receive Veklury treatment.”
Francisco Marty, MD, Associate Professor of Medicine at Harvard Medical School and an infectious disease specialist in the Department of Medicine at Brigham and Women’s Hospital, stated: “As our understanding of the spectrum of SARS-CoV-2 infection and the presentation and severity of COVID-19 continues to evolve, these results and the expanded EUA represent an important new step that simplifies bedside prescribing of Veklury without having to wait for patients’ clinical conditions to worsen. These findings indicate that patients with moderate COVID-19 can also benefit from a 5-day course of Veklury treatment.”(Bioon.com)