The FDA has issued emergency use authorization for Gilead Science Inc’s (GILD) antiviral drug Remdesivir for the treatment of COVID-19 in adults and children hospitalized with severe disease.
Severe disease is defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator, according to the FDA.
In clinical trials, intravenously administered Remdesivir has been shown to shorten the time to recovery in some COVID-19 patients. However, little is known about the safety and effectiveness of using the drug to treat people in the hospital with COVID-19.
But in the absence of adequate, approved, or available alternative treatments, the FDA has determined that it is reasonable to believe that Remdesivir may be effective in treating COVID-19 based on the scientific evidence available.
The U.S. government will coordinate the donation and distribution of Remdesivir to hospitals in cities most heavily impacted by COVID-19, noted Gilead.
A number of clinical trials are ongoing to generate more data on the safety and efficacy of Remdesivir as a treatment for COVID-19.
Gilead has donated 1.5 million individual doses of Remdesivir, which equates to more than 140,000 treatment courses if administered as a 10-day treatment course, to treat COVID-19 patients at no cost.
Commenting on the development, Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences, said, “This EUA opens the way for us to provide emergency use of Remdesivir to more patients with severe symptoms of COVID-19. 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”.
As of this writing, 1,103,225 people in the United States have been infected with the novel coronavirus and 64,808 people have died due to it. (Source: Johns Hopkins University).
GILD closed Friday’s trading at $79.95, down 4.82%. In after-hours, the stock was up 2.25% at $81.75.
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