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WASHINGTON: The U.S. Food and Drug Administration on Thursday (Oct. 22) approved Gilead Sciences’ antiviral drug remdesivir for the treatment of hospitalized patients with COVID-19, making it the first and only drug approved. for disease in the United States.
Remdesivir, administered intravenously, was one of the drugs used to treat US President Donald Trump during his fight with COVID-19.
Formal FDA approval comes just hours before the president’s final debate with Democratic rival Joe Biden ahead of the November 3 presidential election.
Remdesivir has been available under an emergency use authorization from the FDA (US) since May, after a study led by the National Institutes of Health showed it reduced hospital stays by five days.
However, the World Health Organization (WHO) said last week that its global trial of COVID-19 therapies found that remdesivir did not have a substantial effect on patients’ length of hospital stay or chances of survival. This study has not been reviewed by external experts.
Gilead has questioned the potential for bias in the WHO study, which was not “blinded,” meaning that patients and their doctors knew what treatments were being used.
Remdesivir, which will be sold under the Veklury brand, costs $ 3,120 for a five-day course of treatment, or $ 2,340 for government buyers like the Department of Veterans Affairs. Gilead shares were up 4.3 percent in after-hours trading to $ 63.30.
Remdesivir has become the standard of care for hospitalized patients with severe COVID-19, although it has not been shown to improve survival. The drug has also not been shown to significantly help moderately ill patients, and many physicians are wary of using it in patients with less severe illnesses.
“Formal FDA approval does not change our estimates (of sales) or outlook for remdesivir since it has already been rated as standard of care prior to formal approval,” Raymond James analyst Steven Seedhouse said in a note from research, referring to prescribing guidelines. and approval “practically the best case for Gilead”, given the WHO results that question the benefits of remdesivir.
Gilead said it is currently meeting demand for the drug in the United States and anticipates meeting global demand by the end of October.
The company said Veklury has regulatory approvals or temporary authorizations in an additional 50 countries.
Also Thursday, the FDA issued a new emergency use authorization for remdesivir to treat hospitalized pediatric patients younger than 12 years old who are heavy enough to receive a drug intravenously.
Gilead said it is still working to understand the full potential of remdesivir, in different settings and as part of combination therapy approaches. The company is also developing an inhaled version of the drug that could be used outside of a hospital, if approved.
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