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The FDA had previously granted an emergency authorization to use the drug on patients although it hadn’t been formally approved until now.
The drug has gotten mixed reviews by public health officials.
Dr. Anthony Fauci, the nation’s foremost expert on infectious diseases, described the drug earlier this year as “a new standard of care” for coronavirus patients.
But the World Health Organization also conducted a study that last week concluded the drug has “little or no effect” on death rates among hospitalized patients.
As of Thursday, the virus has infected more than 41.5 million people worldwide and killed more than 1.1 million, including more than 222,000 in the United States, according to Johns Hopkins University.
Gilead said in August that it planned to produce more than 2 million doses of the drug by the end of 2020 and “several million more” in 2021, according to CNBC. Supplies of the drug and its manufacturing network have increased dramatically since January, the outlet reported.
“Since the beginning of the COVID-19 pandemic, Gilead has worked relentlessly to help find solutions to this global health crisis,” said Gilead CEO Daniel O’Day in a company statement, according to CNBC. “It is incredible to be in this 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.”
Veklury is approved for people at least 12 years old and weighing at least 88 pounds who are hospitalized for a coronavirus infection. For patients younger than 12, the FDA will still allow the drug’s use in certain cases under its previous emergency authorization, according to the AP.
The drug works by inhibiting a substance the virus uses to make copies of itself. Certain kidney and liver tests are required before starting patients on it to ensure it’s safe for them and to monitor for any possible side effects, the AP reported. And the label warns against using it with the malaria drug hydroxychloroquine because that can curb its effectiveness.
Previous reporting by the AJC said the average cost for a five-day regimen of the drug was $3,120 for patients who had private insurance.
Gilead charges $2,340 for a typical treatment course for people covered by government health programs in the United States and other developed countries, and $3,120 for patients with private insurance. The amount that patients pay out of pocket depends on insurance, income and other factors.
So far, only steroids such as dexamethasone have been shown to cut the risk of dying of COVID-19. The FDA also has given emergency authorization to using the blood of survivors, and two companies are seeking similar authorization for experimental antibody drugs.
Information provided by The Associated Press was used to supplement this report.