U.S. regulators said Friday that they have authorized the emergency use of the experimental anti-viral drug remdesivir for treating coronavirus patients, saying that clinical trials have showed "promising results."
"While there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19, the investigational drug was shown in a clinical trial to shorten the time to recovery in some patients," the U.S. Food and Drug Administration said in a statement.
The move, which will enable the drug to be used for those hospitalized with severe illness caused by the new coronavirus, is a "significant step" forward in battling the pandemic, Secretary of Health and Human Services Alex Azar said in a statement.
The company said it aims to produce at least 500,000 treatment courses by October, 1 million treatment courses by December and millions more in 2021, if required.
Remdesivir was developed by U.S. biopharmaceutical company Gilead Sciences Inc. as a possible treatment for Ebola, but it has not been licensed or approved anywhere globally.
Clinical trials have been under way to confirm the effectiveness and safety of its use for coronavirus patients around the world, including Japan.
The Japanese government is looking to fast-track its approval. The drug is expected to be available in Japan as early as this month, a government official said.
Under the emergency use authorization, remdesivir will be distributed in the United States and administered intravenously by health care providers for patients with low blood oxygen levels as well as those needing oxygen therapy or more intensive breathing support such as a mechanical ventilator.
More than 1 million people in the United States have been infected with the coronavirus, with the country's death toll exceeding 64,000, according to a tally by Johns Hopkins University.
Globally, there have been more than 3 million confirmed cases of COVID-19, the respiratory illness caused by the virus, and more than 230,000 deaths.