The Food and Drug Administration approved Gilead Sciences' antiviral drug Remdesivir for the treatment of the coronavirus on Thursday.
In May, the FDA granted the drug emergency approval, which allowed hospitals and doctors to use it on patients hospitalized with the disease even though the drug had not been officially approved by the agency. The intravenous drug has helped shorten the recovery time for some hospitalized Covid-19 patients. It was one of the drugs used to treat President Donald Trump that tested positive for the virus earlier this month.
The drug is used for Covid-19 patients who are at least 12 years old and in need of hospitalization, Gilead said. Remdesivir is now the first and only fully approved treatment in the U.S. for Covid-19, which infected more than 41.3 million people and killed more than 1 million people worldwide, according to Johns Hopkins University.
Gilead's stock rose more than 5% in after-hours trading.
"Since the beginning of the COVID-19 pandemic, Gilead has worked tirelessly to find solutions to this global health crisis," Gilead CEO Daniel O & # 39; Day said in a statement. "It is incredible today, less than a year after the earliest case reports of the disease now known as COVID-19, to be able to have an FDA-cleared treatment in the US for all eligible patients in need is available. ""
Remdesivir is approved or approved for temporary use as a Covid-19 treatment in around 50 countries worldwide, according to the company.
The drug is given through an IV in a hospital. The company said the drugs should only be given in a hospital or healthcare facility that can provide acute care comparable to inpatient hospital care.
Earlier this month, a study coordinated by the World Health Organization had shown that the drug had "little or no effect" on hospital death rates. Still, it has been shown to be modestly effective in reducing the recovery time of some hospital patients.
Earlier this year, Dr. Anthony Fauci, the nation's leading infectious disease expert, said the drug would "set a new standard for care" for Covid-19 patients.
The majority of patients treated with Remdesivir receive a five-day course with six vials of the drug. The company is also developing an inhaled version of the drug that is administered via a nebulizer, a delivery device that can turn liquid drugs into mist. The company has said the drug cannot be given in pill form because its chemical makeup would affect the liver.
Remdesivir, now under the brand name Veklury, costs $ 2,340 for a five-day treatment course for people covered by government health programs and health systems in other countries, and $ 3,120 for US patients with private health insurance.
In August, the company announced it would produce more than 2 million remdesivir treatment courses by the end of the year and expected to produce "several million more" in 2021. The range of drugs has increased more than fivefold since January. The production network now includes more than 40 companies in North America, Europe and Asia.
The company announced Thursday that it was meeting real-time demand for the drug in the U.S. and expects to meet global demand this month, even in the event of a possible future spike in Covid-19 cases.