Citing "known and potential benefits" of using Gilead Sciences Inc.'s remdesivir for the treatment of COVID-19 that "outweigh the known and potential risks of the drug's use," the FDA has issued an emergency use authorization (EUA) for the antiviral, currently in limited supply, according to the company. Gilead CEO Daniel O’Day, who said the company is working with partners across the globe to ramp up supply, said his team is working with "urgency and responsibility" to meet global needs for the medicine.
"There's tremendous interest among all parties to identify and arm ourselves with medicines to combat COVID-19, and through our Coronavirus Treatment Acceleration Program, the FDA is working around-the-clock and using every tool at our disposal to speed these efforts," said FDA Commissioner Stephen Hahn.
Remdesivir is authorized for the treatment of hospitalized patients with severe COVID-19 disease. Under the EUA, a 10-day dosing regimen of the drug is suggested for patients requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO). By contrast, a five-day dosing duration is suggested for patients not requiring either or both of those interventions.
The EUA is based on available data from two global 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 phase III SIMPLE study, evaluating both the shorter and longer-duration treatment approaches.
Assuming a 10-day treatment course, Gilead said its donation of 1.5 million individual doses of remdesivir equates to more than 140,000 treatment courses for COVID-19 patients following potential emergency authorizations and regulatory approvals, including this EUA.
"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," Gilead said. The government will coordinate the donation and distribution of the drug to U.S. hospitals "in cities most heavily impacted by COVID-19," the company added, a process that is likely to court controversy if politicized.
The EUA designations follows an announcement Thursday that the EMA's Committee for Medicinal Products for Human Use has started a rolling review of remdesivir for COVID-19.