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US allows emergency use of the drug remdesivir for COVID-19 treatment
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.
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In this file photo one vial of the drug Remdesivir is seen during a press conference about the start of a study with the Ebola drug Remdesivir in particularly severely ill patients at the University Hospital Eppendorf (UKE) in Hamburg, northern Germany on April 8, 2020, amidst the new coronavirus COVID-19 pandemic. The experimental antiviral drug remdesivir has failed in its first randomized clinical trial to treat the COVID-19 illness, reports said on April 23, 2020, quoting draft documents that were accidentally published by the World Health Organization. Gilead Sciences, the company behind the medicine, disputed how the now deleted post had characterized the findings, saying the data showed a (AFP/Ulrich Perrey)
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 US 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 US biopharmaceutical company Gilead Sciences 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.
