Gilead Sciences Update On The Company’s Ongoing Response To COVID-19

Gilead is working closely with global health authorities to respond to the novel coronavirus (COVID-19) outbreak through the appropriate use of the investigational drug remdesivir. Together with the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS), National Institute of Allergies and Infectious Diseases (NIAID) and Department of Defense (DoD) - CBRN Medical; the China CDC and National Medical Product Administration (NMPA); the World Health Organization (WHO); and researchers and clinicians across Europe and Asia; Gilead is focused on contributing our antiviral expertise and resources to help patients and communities fighting COVID-19.

Access to Remdesivir and Future Study

Gilead is working with regulatory authorities worldwide to map out options to make access to investigational remdesivir more widely available through expedited regulatory processes globally should it demonstrate the potential to be a safe and effective treatment option based on the results of preliminary clinical trials.

In the United States, the Food and Drug Administration (FDA) has authorized the emergency use of remdesivir to treat hospitalized adult and pediatric patients with suspected or laboratory confirmed SARS-CoV-2 infection and severe COVID-19. The FDA’s Emergency Use Authorization will enable appropriate patients more ready access to remdesivir at this time, due to the public health emergency. Remdesivir has not been approved by the FDA for any use, and the safety and efficacy of remdesivir for the treatment of COVID-19 are not yet established. For information about the authorized use of remdesivir and mandatory requirements of the EUA in the United States, please review the Fact Sheet for Healthcare Providers and FDA Letter of Authorization available here.

Gilead is also in discussion with multiple organizations regarding the potential for future trials.

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Last Updated: July 7, 2020