FDA Expands Use of Remdesivir for COVID-19 Treatment

August 31, 2020 – The Federal Drug Administration has expanded its emergency use authorization for the antiviral drug remdesivir to include all hospitalized patients with coronavirus, not just those who are so sick they need ventilators or oxygen therapy.

“Today, as part of its continued efforts to combat COVID-19, the United States Food and Drug Administration has expanded the scope of the existing Emergency Use Authorization (EUA) of the drug Veklury (remdesivir) to include the treatment of all hospitalized adult and pediatric patients. with suspected or laboratory confirmed COVID-19, regardless of the severity of the disease, ”the FDA said in a press release on Friday.

Remdesivir was originally developed for hepatitis C and Ebola virus, and has been shown to shorten the recovery time of people with severe coronavirus. Peer-reviewed data indicates that the median recovery time for coronavirus patients who received remdesivir was 11 days, compared to 15 days for those who received placebo.

In May, the FDA approved remdesivir for coronavirus patients who were critically ill, defined as having blood oxygen levels so low that they needed oxygen therapy or ventilators.

With the expanded 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 shows that this treatment has the potential to help even more hospital patients suffering from the effects of this devastating virus,” FDA Commissioner Stephen M. Hahn, MD, said in the press release.

Gilead Sciences, the pharmaceutical company that makes remdesivir, welcomed the move.

“With the growing understanding of Veklury’s utility in helping to improve outcomes for a range of patients with COVID-19, we welcome the FDA’s decision to extend the emergency use authorization” Gilead Sciences chief medical officer Merdad Parsey, MD, said in a press release

“As we learn more about COVID-19 and further establish the efficacy and safety profile of Veklury, we are seeing the benefit of making the drug available to patients at stages early in the disease. Today’s action by the FDA allows physicians to consider a broader range of patients eligible to potentially receive Veklury. “

For a patient with private insurance, Gilead would charge hospitals $ 520 per dose, which would work out to $ 3,120 for a typical six-dose course over 5 days, Gilead said last June. For patients on Medicare or of another government-funded insurance, Gilead would charge $ 390 per dose, or $ 2,340 for six doses.

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Jothi Venkat

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