Emergency Access to Remdesivir Outside of Clinical Trials
Remdesivir is an investigational drug that has not been approved by any regulatory authority, and the safety and efficacy of remdesivir for the treatment of COVID-19 are not yet known. Enrollment in clinical trials is the primary way to access remdesivir to generate critical data that inform the appropriate use of remdesivir. We recognize that enrollment in clinical trials is not feasible for all patients, and in consultation with regulatory authorities we have implemented programs that are designed to provide emergency treatment access for patients with severe clinical manifestations of COVID-19.
Individual compassionate use requests continue to be reviewed for pregnant women and children less than 18 years of age with confirmed COVID-19 and severe manifestations of disease.
Beyond these two populations, Gilead has transitioned the provision of emergency access to remdesivir from individual compassionate use requests to expanded access programs. Our goals with this transition were to manage the volume of requests, expedite the delivery of the drug for patients and enable the gathering of appropriate data.
Expanded access programs are now operational in the United States, Australia, Belgium, Canada, France, Germany, Israel, Italy, the Netherlands, Romania, Spain, Switzerland and the UK. Programs in other countries are currently under rapid development in conjunction with national regulatory authorities worldwide. A list of active sites is available and regularly updated here.
Over time, the expanded access program in the United States will wind down, as the U.S. 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 to more readily access 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.