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The Secretary of the Department of Health and Human Services has declared a public health emergency that justifies the emergency use of remdesivir to treat coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 infection. In response, the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the unapproved product, remdesivir, for the treatment of COVID-19.

Authorized Use

Remdesivir (GS-5734™) is authorized for use under an EUA only for the treatment of patients with suspected or laboratory-confirmed SARS-CoV-2 infection and severe COVID-19. Severe disease is defined as patients with an oxygen saturation (SpO2) ≤94% on room air or requiring supplemental oxygen, mechanical ventilation, and/or extracorporeal membrane oxygenation (ECMO). Remdesivir is authorized for adult or pediatric patients who are admitted to a hospital and for whom use of an IV agent is clinically appropriate. Remdesivir must be administered intravenously.

Access

The US government is coordinating the donation and distribution of remdesivir by determining how much drug each state will receive. State public health departments will identify which local hospitals will receive remdesivir and how much drug each hospital will receive. Gilead and AmerisourceBergen are working under the guidance of the federal and state governments, and state public health departments for the distribution of remdesivir. AmerisourceBergen will ship to locations as directed by the US government.

For further information, please see the HHS May 9, 2020 announcement available here.

Frequently Asked Questions

How is the US government deciding on allocation of donated remdesivir?

The US government is coordinating the donation and distribution of remdesivir by determining how much drug each state will receive. State public health departments will identify which local hospitals will receive remdesivir and how much drug each hospital will receive. Gilead and AmerisourceBergen are working under the guidance of the federal and state governments, and state public health departments for the distribution of remdesivir. AmerisourceBergen will ship to locations as directed by the US government.

For further information, please see the HHS May 9, 2020 announcement available here.

How will I know if my hospital will receive a donation of remdesivir for the treatment of COVID-19?

We are not able to confirm whether specific hospitals are on the list to receive donated remdesivir. Please contact your state public health department for more information about its allocation to local hospitals within your state.

How does my hospital receive remdesivir if it’s not in the AmerisourceBergen network?

The US government has directed hospitals to seek information from state public health departments regarding allocation to specific hospitals. The fact that your hospital is not an AmerisourceBergen customer will not impact the allocation decisions of your state public health department.

How are you allocating available supply of your donated product globally? How much is being reserved for the United States?

The donation is our commitment to provide our existing supply of remdesivir at no cost for the treatment of patients with severe COVID-19 globally. We have donated a portion of our existing supply to the US government. Additional portions are being used for clinical trials, expanded access in other countries, for example.

Gilead will continue to work with health authorities and the US government to determine the appropriate allocation of available product supply for appropriate patients. Post-donation, the company will work closely with governments and healthcare systems to provide access for healthcare providers to prescribe remdesivir for appropriate patients.

How will the EUA impact the US compassionate use and expanded use programs?

Supply of remdesivir through these US programs will continue for patients already receiving or approved to receive remdesivir through these programs. Over time, these programs will wind down as the EUA will enable a faster path for appropriate patients to receive access to remdesivir.

Important Information

The Secretary of the Department of Health and Human Services has declared a public health emergency that justifies the emergency use of remdesivir to treat coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 infection. In response, the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the unapproved product, remdesivir, for the treatment of COVID-19.

  • Remdesivir is an investigational drug that has not been approved by the FDA for any use. It is not yet known if remdesivir is safe and effective for the treatment of COVID-19.
  • The distribution of remdesivir has been authorized only for the treatment of hospitalized patients with severe COVID-19. It is not authorized for the treatment of any other viruses or pathogens.
  • This use is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use, unless the authorization is terminated or revoked sooner.
  • The FDA issued this EUA, requested by Gilead Sciences and based on their submitted data. The FDA Letter of Authorization for the EUA is available here.

Additonal Information for Healthcare Providers:

  • Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of remdesivir and mandatory requirements of the EUA.
  • Remdesivir must be administered intravenously. The optimal duration of treatment for COVID-19 is unknown. The suggested dose durations under this EUA are described in the Fact Sheet for Healthcare Providers, available here.

Healthcare providers and/or their designee are responsible for mandatory FDA MedWatch reporting of all medication errors and serious adverse events or deaths occurring during remdesivir treatment and considered to be potentially attributable to remdesivir. These events must be reported within 7 calendar days from the onset of the event.

MedWatch adverse event reports can be submitted to the FDA online here, or by calling 1-800-FDA-1088.

  • For information about clinical trials that are testing the use of remdesivir for the treatment of COVID-19, please see www.clinicaltrials.gov.

Authorized Use

Remdesivir (GS-5734™) is authorized for use under an EUA only for the treatment of patients with suspected or laboratory-confirmed SARS-CoV-2 infection and severe COVID-19. Severe disease is defined as patients with an oxygen saturation (SpO2) ≤94% on room air or requiring supplemental oxygen, mechanical ventilation, and/or extracorporeal membrane oxygenation (ECMO). Remdesivir is authorized for adult or pediatric patients who are admitted to a hospital and for whom use of an IV agent is clinically appropriate. Remdesivir must be administered intravenously.

Overall Safety Summary

Remdesivir is an unapproved investigational product, and there are limited clinical data available. Serious and unexpected adverse events may occur that have not been previously reported with remdesivir use.

Warnings: In clinical studies with remdesivir, infusion-related reactions and liver transaminase elevations have been observed. Remdesivir should not be used in patients who are hypersensitive to any ingredient of remdesivir. If signs and symptoms of a clinically significant infusion reaction occur, immediately discontinue administration of remdesivir and initiate appropriate treatment. Do not initiate remdesivir in patients with ALT ≥5x ULN; discontinue therapy in patients who develop ALT ≥5x ULN or ALT elevation accompanied by signs or symptoms of liver inflammation or increasing conjugated bilirubin, alkaline phosphatase, or INR.

Patients should have appropriate clinical and laboratory monitoring to aid in early detection of any potential adverse events. Monitor renal and hepatic function prior to initiating and daily during therapy with remdesivir; additionally monitor serum chemistries and hematology daily during therapy. The decision to continue or discontinue remdesivir therapy after development of an adverse event should be made based on the clinical risk/benefit assessment for the individual patient. For additional information and mandatory adverse event reporting, please see the Fact Sheet for Healthcare Providers.

Information about the EUA:

Information about COVID-19:

Gilead is working closely with global health authorities and is focused on contributing our antiviral expertise and resources to help patients and communities impacted by COVID-19.