WASHINGTON (CBS SF) — The U.S. Food and Drug Administration on Thursday gave the green light to remdesivir as the first approved treatment for COVID-19, according to a statement released by the Bay Area biotech company that developed the drug.
The antiviral drug, developed and sold under the brand name Veklury by Foster City-based Gilead Sciences, has been used under emergency use authorization.
The company tweeted about the approval Thursday afternoon.
— Gilead Sciences (@GileadSciences) October 22, 2020
“As an antiviral drug, Veklury works to stop replication of SARS-CoV-2, the virus that causes COVID-19,” the released statement read. “Veklury is now the first and only approved COVID-19 treatment in the United States.”
According to Gilead, the drug is now widely available in hospitals across the country, following early investments to rapidly expand manufacturing capacity to increase supply.
In the United States, the drug will be used to treat COVID-19 patients who are adults as well as pediatric patients at least 12 years of age and older and weighing at least 40 kilograms. The release says the drugs “should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.”
Earlier this month, a World Health Organization-sponsored global study found remdesivir did not help patients survive or even recover faster, but a U.S. study found the infused drug shortened recovery time for some patients by about a third.
Gilead Sciences has been criticized for how much the drug costs, with a typical treatment course for people covered by government health programs in the United States and other developed countries running about $2,340.
The price would be $3,120 for patients with private insurance.