FDA approves controversial drug to treat COVID-19
The Food and Drug Administration (FDA) has approved Gilead Sciences' remdesivir as a drug for the treatment of coronavirus disease, writes CNBC.
In May, the FDA granted an emergency use authorization for the drug, allowing hospitals and doctors to use it for patients hospitalized with COVID-19, although remdesivir has not been formally approved by the agency. Its intravenous administration has helped to shorten the recovery time of some hospitalized patients with COVID-19 disease. It was one of the drugs used to treat President Donald Trump, who tested positive for the virus in early October.
Remdesivir will be used for COVID-19 patients over 12 years of age who need hospital care, Gilead said. It is currently the first and only fully approved drug in the United States for the treatment of coronavirus disease.
On the subject: Hopes dashed: remdesivir does not help patients with COVID-19
“Since the outbreak of the COVID-19 pandemic, Gilead has worked tirelessly to help find solutions to this global health crisis,” said Gilead CEO Daniel O'Day. "It's incredible that today, less than a year after the first reports of cases of the disease known as COVID-19, there is FDA-approved treatment in the US available to all eligible patients who need it."
According to the company, remdesivir is approved or approved for temporary use as a drug for COVID-19 in about 50 countries around the world.
It is administered in a hospital setting through a drip. The company said remdesivir should only be administered in a hospital or health care facility capable of providing care comparable to inpatient care.
Earlier this month, a study coordinated by the World Health Organization found the drug had “little or no effect” on mortality rates among hospitalized patients. However, it has shown modest effectiveness in shortening the recovery time for some hospitalized patients.
Earlier this year, Dr. Anthony Fauci, the country's leading infectious disease expert, said the drug would set a “new standard of care” for COVID-19 patients.
The majority of patients receiving remdesivir are treated with a five-day course using six vials of the drug. The company is also developing an inhalation version of it that can be administered through a nebulizer - a dispenser capable of converting liquid drugs into an aerosol. The company said the drug should not be taken in pill form, as its chemical composition would affect the liver.
Remdesivir, now marketed under the Veklury brand, costs $ 2340 for a five-day course of treatment for people covered by national and international health systems, and $ 3120 for US patients with private health insurance.
In August, the company announced that it plans to deliver more than 2 million courses of remdesivir by the end of the year, and in 2021 it is expected to be able to make “several million more,” clarifying that since January 2020, the supply of the drug has increased by more than fifty times. Its manufacturing network currently includes over 40 companies in North America, Europe and Asia.
On Thursday, October 22, the company said it is meeting real-time U.S. demand for the drug and expects to meet global demand this month, even in the event of a potential future surge in COVID-19 cases.
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