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LOS ANGELES – The United States Food and Drug Administration (FDA) approved this Thursday the authorization for the use of the antiviral drug remdesivir, by the pharmaceutical company Gilead Sciences Inc’s, in the treatment of Covid-19, making -the first and the only drug approved for the disease in the country.
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Remdesivir, administered intravenously, was one of the substances used in the treatment of the President of the United States, Donald Trump, against Covid-19.
The drug has been available for treatment under an emergency use authorization from the FDA since May, after a study led by the National Institutes of Health showed it helped reduce hospital stays by five days.
But the World Health Organization (WHO) announced last week that its global treatment studies for Covid-19 concluded that remdesivir did not have a substantial effect on reducing patients’ time in hospital or their chances of survival. The study has not yet been reviewed by external experts.
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Gilead questions the possibility of bias in the WHO study, which was not “double-blind,” meaning that the participants and their doctors knew what drugs were being used.
Remdesivir, which will be sold under the Veklury brand in the US, costs $ 3,120 for a five-day treatment, or $ 2,340 for government buyers like the Department of Veterans Affairs. Gilead shares rose 4.3% on the stock market to $ 63.30.
Gilead said it is meeting demand for the drug in the United States and expects to meet global demand by the end of October. The company said Veklury has regulatory approvals or temporary permits in about 50 other countries.
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Also Thursday, the FDA issued a new emergency use authorization to ease the treatment of inpatient pediatric patients under 12 years of age who weigh enough to receive a drug intravenously.
Gilead said it is still working to understand the full potential of remission, in different settings and as part of combination therapy approaches. The company is also developing an inhaled version of the drug that can be used outside of the hospital setting, if approved.
