FDA approves Gilead's remdesivir as first COVID-19 treatmen
Oct. 22, 2020 (Fox Business) — Gilead Science’s antiviral drug remdesivir has been given the green light by the Food and Drug Administration as the first officially approved COVID-19 treatment.
The antiviral was just one of the treatments President Trump received during his recent bout with the coronavirus.
“Since the beginning of the COVID-19 pandemic, Gilead has worked relentlessly to help find solutions to this global health crisis,” Gilead Chairman and 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.”
The approval comes following new results published in the New England Journal of Medicine Thursday from Gilead’s Phase 3 ACTT-1 trial, which demonstrated faster recovery times than previously reported for the treatment of adults hospitalized with mild-moderate or severe coronavirus cases. Remdesivir was also found to reduce disease progression among severely ill patients who require oxygen.
According to the FDA, remdesivir will be used on patients who are 12 years and older and should “only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.”
The drug, sold under the brand name Veklury, has previously been allowed under emergency use authorization given to Gilead in May.