August 31, 2020 — The Federal Drug Administration has broadened its emergency use authorization for the anti-viral drug remdesivir to include all hospitalized coronavirus patients, not just those who are so ill they require ventilators or oxygen therapy.
“Today, as part of its ongoing efforts to fight COVID-19, the U.S. Food and Drug Administration broadened the scope of the existing emergency use authorization (EUA) for the drug Veklury (remdesivir) to include treatment of all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of disease,” the FDA said Friday in a news release.
Remdesivir was originally developed for hepatitis C and Ebola that has been shown to shorten the recovery time for people severely ill with coronavirus. Peer-reviewed data indicates the median recovery time for coronavirus patients who received remdesivir was 11 days, compared to 15 days for those who received a placebo.
In May, the FDA approved remdesivir for coronavirus patients who were severely ill, defined as having blood oxygen levels so low they needed oxygen therapy or ventilators.
With the broadened authorization, the drug can be used to treat “suspected or laboratory-confirmed COVID-19 in all hospitalized adult and pediatric patients,” the FDA said.
“The data show that this treatment has the potential to help even more hospitalized patients who are suffering from the effects of this devastating virus,” FDA Commissioner Stephen M. Hahn, M.D., said in the news release.
Gilead Sciences, the drug company that makes remdesivir, praised the decision.
“With the growing understanding of the utility of Veklury to help improve outcomes for a range of patients with COVID-19, we welcome the FDA’s decision to expand emergency use authorization,” Merdad Parsey, MD, chief medical officer for Gilead Sciences, said in a news release
“As we learn more about COVID-19 and we further establish the efficacy and safety profile of Veklury, we see benefit to making the drug available to patients at earlier stages of the disease. Today’s action by the FDA enables physicians to consider a broader range of eligible patients to potentially receive Veklury.”
For a patient with private insurance, Gilead would charge hospitals $520 per dose, which would come to $3,120 for a typical treatment of six doses over 5 days, Gilead said last June.For patients with Medicare or other government-sponsored insurance, Gilead would charge $390 per dose, or $2,340 for six doses.