This week, the US Food and Drug Administration (FDA) approved the emergency use of the antiviral remdesivir as the country’s first drug treatment for COVID-19.
The emergency use approval (EUA) was issued after a government-sponsored study of 1,063 patients found that hospitalized COVID-19 patients treated with the drug recovered an average of 4 days faster than those who were not treated with the drug—a 31% improvement in recovery time.
The treatment, which was developed by Gilead Sciences Inc., may be approved for expanded use provided that additional research can be conducted on the efficacy and safety of the drug.
The EUA allows for remdesivir to be distributed in the U.S. and administered intravenously by health care 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.
“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,” he added.
Based on evaluation of the emergency use authorization criteria and the scientific evidence available, it was 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.
“The results from the global, placebo-controlled trial run by the National Institute of Allergy and Infectious Diseases (NIAID) are positive. They show that patients with COVID-19 who received remdesivir recovered faster than similar patients who received placebo,” said Gilead Chairman and CEO Daniel O’Day in a statement.
“There is still more work to do and remdesivir has not been approved, but all of us at Gilead are humbled by what these promising results might mean for patients. After years of research and hard work on remdesivir, there is relief and gratitude among our teams today that their efforts have been so worthwhile.
“Since January, our teams have been working day and night to determine whether remdesivir might work in patients with COVID-19. These efforts include collaboration with study investigators and governments on the various clinical trials. Today’s news, that remdesivir might play a role in easing the burden of the pandemic, is the outcome we all hoped would be possible.”