Gilead was granted EUA by U.S. FDA for the investigational antiviral remdesivir to treat COVID-19. The EUA will facilitate broader use of remdesivir to treat hospitalized patients with severe COVID-19 disease, enabling access to remdesivir at additional hospitals across the country. Allocation of the currently limited available supply of remdesivir will be made based on guiding principles that aim to maximize access for appropriate patients in urgent need of treatment, with direction from and in collaboration with the government.
The optimal duration of treatment is still being studied in ongoing clinical trials. Under the EUA, both 5-day and 10-day treatment durations are suggested, based on the severity of disease. The authorization is temporary and does not 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 only for the treatment of COVID-19; remdesivir remains an investigational drug and has not been approved by FDA.
The U.S. government will coordinate the donation and distribution of remdesivir to hospitals in cities most heavily impacted by COVID-19. Gilead is working with the U.S. government on the logistics of remdesivir distribution and will provide more information when the company begins shipping the drug under the EUA.
The EUA is based on available data from two global clinical trials – the National Institute for Allergy and Infectious Diseases’ placebo-controlled Phase III study in patients with moderate to severe symptoms of COVID-19, including those who were critically ill, and Gilead’s global Phase III study evaluating 5-day and 10-day dosing durations of remdesivir in patients with severe disease.
As previously announced, 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. Assuming a 10-day treatment course, Gilead’s donation of 1.5 million individual doses of remdesivir equates to more than 140,000 treatment courses that will be provided at no cost.
