FDA Expands EUA for SBECD-enabled Remdesivir

Posted by

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

Gilead Sciences announced the U.S. Food and Drug Administration (FDA) expanded the Emergency Use Authorization (EUA) enabling use of the investigational antiviral Veklury® (remdesivir) to treat all hospitalized patients with COVID-19, in addition to the previous authorization for patients hospitalized with severe COVID-19. The expanded EUA is based on results from the Phase 3 SIMPLE trial evaluating Veklury in hospitalized patients with moderate COVID-19 pneumonia, as well as results from the National Institute of Allergy and Infectious Diseases (NIAID) ACTT-1 trial in hospitalized patients with a range of disease severity.

“With the growing understanding of the utility of Veklury to help improve outcomes for a range of patients with COVID-19, we welcome the FDA’s decision to expand emergency use authorization,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “As we learn more about COVID-19 and we further establish the efficacy and safety profile of Veklury, we see benefit to making the drug available to patients at earlier stages of the disease. Today’s action by the FDA enables physicians to consider a broader range of eligible patients to potentially receive Veklury.”

Results from the Phase 3 SIMPLE study were published in the Journal of the American Medical Association (JAMA) on August 21, 2020 and confirm top-line results previously announced on June 1, 2020. The primary endpoint evaluated patients at Day 11 on a 7-point ordinal scale and found patients randomized to a 5-day course of Veklury plus standard of care were 65 percent more likely to have an improvement in clinical status compared with those randomized to standard of care alone (OR, 1.65; 95% confidence interval, 1.09-2.48; p=0.017). For patients in the 10-day Veklury group, the improvement in clinical status at Day 11 was not statistically different compared with the standard of care group (OR, 1.31; 95% confidence interval, 0.88-1.95; p=0.183).

The data published in JAMA demonstrate that Veklury was generally well-tolerated in both the 5-day and 10-day treatment groups. The most commonly reported adverse events in the 5-day, 10-day, and standard of care groups, respectively, 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%). All-cause mortality at Day 28 was ≤ 2% in all treatment groups.

About Veklury (remdesivir)

Veklury is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens. Multiple ongoing international Phase 3 clinical trials are evaluating the safety and efficacy of Veklury for the treatment of SARS-CoV-2 infection, the virus that causes COVID-19, in different patient populations, formulations, and in combination with other therapies.

In the United States, Veklury (remdesivir) is authorized for use under an Emergency Use Authorization (EUA) only for the treatment of hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19. Veklury must be administered via intravenous (IV) infusion and is supplied two ways: Veklury (remdesivir) for injection, 100 mg, lyophilized powder, or Veklury (remdesivir) injection, 100 mg/20 mL (5 mg/mL), concentrated solution.

Veklury is an investigational drug that has not been approved by the FDA for any use, and the safety and efficacy of Veklury for the treatment of COVID-19 have not been established. This authorization is temporary and may be revoked, and does not take the place of the formal new drug application submission, review and approval process. For information about the authorized use of Veklury and mandatory requirements of the EUA in the U.S., please review the Fact Sheets and FDA Letter of Authorization available at www.gilead.com/remdesivir.

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.