COVID-19 Frequently Asked Questions | FDA

COVID-19 Frequently Asked Questions | FDA

The FDA is working to address the coronavirus disease (COVID-19) outbreak and keep you and your family informed on the latest developments. Here are answers to some frequently asked questions from consumers about the clinical trials and Emergency Use Authorizations for remdesivir.

Q: Is Veklury (remdesivir) approved by the FDA to treat COVID-19?

A: No. Veklury (remdesivir) is an investigational antiviral drug. It is not currently FDA-approved to treat or prevent any diseases, including COVID-19.

In August 2020, Gilead announced publicly the submission of their New Drug Application for Veklury (remdesivir) for the treatment of COVID-19.

In May 2020, the FDA issued an Emergency Use Authorization (EUA) that authorized Veklury for the treatment of certain hospitalized adult and pediatric patients with severe COVID-19. On Aug. 28, 2020, based on the agency’s ongoing review of the EUA, including its review of the totality of scientific information now available, the FDA has determined that it is reasonable to believe Veklury may be effective for the treatment of suspected or laboratory-confirmed COVID-19 in all hospitalized adult and pediatric patients. The FDA’s review has also concluded that the known and potential benefits of Veklury outweigh the known and potential risks for these uses.

Q: Are there data showing Veklury (remdesivir) might benefit patients with COVID-19?

A: The safety and efficacy of Veklury (remdesivir) for the treatment of COVID-19 are being evaluated in multiple ongoing clinical trials. Data from multiple phase 3 clinical trials suggest that Veklury (remdesivir) might benefit patients with COVID-19.

Because Veklury (remdesivir) may help hospitalized patients, the FDA is allowing this drug to be provided to hospitalized patients, irrespective of disease severity, under an expansion of the EUA issued on Aug. 28, 2020. Under the EUA, health care providers and patients are provided with information about the risks of Veklury (remdesivir). However, a review of final data from clinical trials included in the New Drug Application (NDA) is necessary for us to determine whether the drug is safe and effective in treating COVID-19.

Q: How can Veklury (remdesivir) be obtained for use under the EUA?

A: The Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) announced the allocation plan for Veklury (remdesivir) in May 2020. On June 29, 2020, HHS announced an agreement between HHS and Gilead to secure large supplies of Veklury (remdesivir) through September 2020.

These supplies will be allocated in the same way that Gilead’s donation of approximately 120,000 treatment courses of Veklury (remdesivir) were allocated: HHS allocates product to state and territorial health departments based on COVID-19 hospital burden, and health departments allocate it to hospitals. Health care providers interested in administering Veklury (remdesivir) in accordance with the authorized use under the EUA should contact their state health department. More information about allocation of Veklury (remdesivir) can be found here.