Gilead Sciences, Inc. announced on Friday that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the investigational antiviral remdesivir to treat COVID-19. The authorization came after their government-funded Phase III SIMPLE trial, which evaluated 5-day and 10-day dosing of the antiviral remdesivir in hospitalized patients with severe cases of COVID-19, showed promising results. The study found that patients who took remdesivir recovered faster than patients who did not, improving recovery time for coronavirus patients from 15 to 11 days.
“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, in a statement released on Friday. “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.”
Gilead has since donated their “entire supply” of the medication, with O’Day telling CBS’ “Face the Nation” on Sunday, “We’ve donated the entire supply that we have within our supply chain and we did that because we acknowledge and recognize the human suffering, the human need here, and want to make sure nothing gets in the way of this getting to patients.”
Remdesivir is currently the only authorized treatment of hospitalized patients with severe COVID-19 disease.