FDA Approves Gilead's Remdesivir as Coronavirus Treatment

Sign with logo for pharmaceutical company Gilead in the Silicon Valley, Foster City, California, April 11, 2020.
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The Food and Drug Administration on Thursday approved Gilead Sciences' antiviral drug remdesivir as a treatment for the coronavirus.

In May, the FDA granted the drug an emergency use authorization, allowing hospitals and doctors to use it on patients hospitalized with the disease even though the medication had not been formally approved by the agency. The intravenous drug has helped shorten the recovery time of some hospitalized COVID-19 patients. It was one of the drugs used to treat President Donald Trump, who tested positive for the virus earlier this month.

The drug will be used for COVID-19 patients at least 12 years old and requiring hospitalization, Gilead said. Remdesivir is now the first and only fully approved treatment in the U.S. for COVID-19, which has infected more than 41.3 million people worldwide and killed more than 1 million, according to data compiled by Johns Hopkins University.

Shares of Gilead were up more than 5% in after-hours trading.

"Since the beginning of the COVID-19 pandemic, Gilead has worked relentlessly to help find solutions to this global health crisis," Gilead CEO Daniel O’Day said in a statement. "It is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as COVID-19, of having an FDA-approved treatment in the U.S. that is available for all appropriate patients in need."

Remdesivir is approved or authorized for temporary use as a COVID-19 treatment in approximately 50 countries worldwide, according to the company.

The drug is administered in a hospital setting via an IV. The company said the drug should only be administered in a hospital or in a health-care setting capable of providing acute care comparable to inpatient hospital care.

Earlier this month, a study coordinated by the World Health Organization had indicated that the drug had "little or no effect" on death rates among hospitalized patients. Still, the drug has shown to be modestly effective in reducing the recovery time in some hospitalized patients.

Earlier in the year, Dr. Anthony Fauci, the nation’s leading infectious disease expert, said the drug would set "a new standard of care" for COVID-19 patients.

The majority of patients treated with remdesivir receive a five-day treatment course using six vials of intravenous the drug. The company is also developing an inhaled version of the drug, which it will administer through a nebulizer, a delivery device that can turn liquid medicines into mist. The company has said the drug can’t be administered in pill form because its chemical makeup would impact the liver.

In August, the company said it planned to produce more than 2 million treatment courses of the drug by the end of the year and anticipated being able to make "several million more" in 2021, adding it has increased the supply of the drug more than fiftyfold since January. Its manufacturing network now includes more than 40 companies in North America, Europe and Asia.

The company said Thursday it is meeting real-time demand for the drug in the United States and anticipates meeting global demand in October, even in the event of potential future surges of COVID-19 cases.

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