FOSTER CITY, Calif.—May 1 brought word that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for Gilead Sciences’ investigational antiviral remdesivir, in order to treat COVID-19. The EUA will facilitate the broader use of remdesivir in treating hospitalized patients with severe COVID-19, and enable access to remdesivir at more hospitals across the country.
Gilead says that allocation of the currently limited available supply of remdesivir is meant to maximize access for appropriate patients in urgent need of treatment, with direction from and in collaboration with the government. The FDA has authorized distribution of this medicine with accompanying fact sheets, which can be accessed here.
“This EUA opens the way for us to provide emergency use of remdesivir to more patients with severe symptoms of COVID-19,” said Daniel O’Day, chairman and chief executive officer of Gilead Sciences. “We will continue to work with partners across the globe to increase our supply of remdesivir while advancing our ongoing clinical trials to supplement our understanding of the drug’s profile. We are working to meet the needs of patients, their families and healthcare workers around the world with the greatest sense of urgency and responsibility.”
Remdesivir is authorized for the treatment of hospitalized patients with severe COVID-19. The optimal duration of treatment is still being studied in ongoing clinical trials. Under the EUA, both 5- and 10-day treatment durations are suggested, based upon disease severity.
The EUA is based on available data from two global clinical trials — the National Institute for Allergy and Infectious Diseases’ placebo-controlled Phase 3 study in patients with moderate to severe symptoms of COVID-19, including those who were critically ill, and Gilead’s global Phase 3 study evaluating 5- and 10-day dosing durations of remdesivir in patients with severe disease. Multiple additional clinical trials are ongoing to generate more data on the safety and efficacy of remdesivir as a treatment for COVID-19.
This authorization is temporary, and won’t take the place of the formal New Drug Application submission, review and approval process. The EUA allows for the distribution and emergency use of remdesivir solely for the treatment of COVID-19. Remdesivir remains an investigational drug and has not been approved by the FDA.
The U.S. government plans to coordinate the donation and distribution of remdesivir to hospitals in the cities which have been most heavily impacted by COVID-19. Given the severity of illness of patients appropriate for remdesivir treatment, and the limited availability of drug supply, hospitals with intensive care units and other hospitals that the government deems most in need will receive priority in the distribution. Gilead says that the company is working with the government on the logistics of remdesivir distribution, and will provide more information when the company begins shipping the drug under the EUA.
Remdesivir must be administered intravenously, and the optimal dosing and duration of remdesivir for the treatment of COVID-19 is still unknown. Under this EUA, the 10-day dosing duration is suggested for patients requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO). If a patient on the 5-day dosing duration does not demonstrate clinical improvement after five days, treatment may be extended for up to five additional days (10 days total).
Gilead has donated the entirety of its existing supply of finished and unfinished product to help address the urgent medical needs posed by this pandemic around the world. The company will continue to support clinical trials, and expanded access and compassionate use programs for remdesivir. Gilead also plans to evaluate global allocation of supply on an ongoing basis using multiple, independent data sources to track the incidence and severity of the outbreak.
Gilead has supplemented internal manufacturing with additional capacity from multiple partners in North America, Europe and Asia. The company has set a goal of producing at least 500,000 treatment courses by October, 1 million treatment courses by December 2020 and millions more in 2021, if required.