FDA Approves First Treatment for COVID-19, Remdesivir

The U.S. Food and Drug Administration on Thursday approved Gilead Sciences’s antiviral drug remdesivir for the treatment of adults with COVID-19, making it the first and only FDA-approved treatment for the disease in the United States. Gilead Sciences has branded its version of remdesivir as “Veklury.” It is administered intravenously to hospitalized patients. “Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care,” the FDA announced, noting that the drug is being formally approved—beyond an emergency use authorization—for use in patients aged 12 and older, weighing at least 40 kilograms (about 88 pounds). The FDA also on Thursday issued a new emergency use authorization (EUA) for remdesivir to treat hospitalized pediatric patients under age 12 who weigh at least 3.5 kg—enough to receive an intravenous drug. Velukry has been available under an FDA EUA since May, after a study (ACTT-1 trial) …