The US FDA issued an emergency use authorization for remdesivir, an investigational antiviral drug for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.
According to the FDA, limited information is known about the safety and effectiveness the drug for COVID-19, however, a clinical trial recently found the drug could shorten the time to recovery in some patients. Additional trials are underway.
The EUA allows for remdesivir to be distributed in the US and administered intravenously by healthcare providers, as appropriate, to treat suspected or laboratory-confirmed 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.
“From day one, the FDA has been committed to expediting the development and availability of potential COVID-19 treatments. Today’s action is an important step in our efforts to collaborate with innovators and researchers to provide sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective,” said FDA commissioner Stephen M. Hahn, MD. “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.”