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FDA’s EUA provides the first new treatment for COVID-19 patients with severe symptoms.
FDA issued on May 1, 2020 an emergency use authorization (EUA) for Gilead Sciences’ investigational antiviral drug remdesivir, the first new treatment for adults and children hospitalized with severe COVID-19 disease. In a recent clinical trial conducted by the National Institutes of Health, the investigational drug was shown to shorten the recovery time for some patients.
The EUA allows for remdesivir to be administered in the United States to treat suspected or laboratory-confirmed COVID-19 in patients with low blood oxygen levels or those needing oxygen therapy or more intensive breathing support such as a ventilator. Remdesivir is an investigational drug that has not been approved by FDA.
In a statement announcing the EUA, FDA noted that based on the scientific evidence available, the agency determined that “it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use.”
“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 May 1, 2020 press statement. “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 reported that the government will determine the distribution of the therapy to hospitals in impacted areas. The company has donated 1.5 million individual doses of remdesivir, which for a 10-day treatment course would provide more than 140,000 treatment courses.
To meet additional demand, the company reports that it has shortened the manufacturing lead time from raw materials through to finished product and supplemented internal capacity with external manufacturing in North America, Europe, and Asia. Production goals are 500,000 treatment courses by October 2020, one million treatment courses by December 2020, and millions more in 2021, if required, the company reported.