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The FDA for treating hospitalized COVID-19 patients, a first for the disease that started a global pandemic.

Remdesivir, an antiviral that works by limiting SARS-CoV-2 replication, is indicated for hospitalized patients age 12 and up (and at least 40 kg [88.2 lbs]). Previously, the intravenous drug was solely available under an emergency use authorization (EUA) from the agency.

FDA also announced a new EUA for remdesivir in hospitalized kids age 12 and older weighing at least 3.5 kg (7.7 lbs) but less than 40 kg, and in kids under age 12 weighing at least 3.5 kg.

The news comes exactly a week after a major international trial led by the World Health Organization (WHO) found no survival improvement for hospitalized COVID-19 patients treated with the drug, and no improvement in time to recovery.

Approval was based on three randomized trials, including the National Institutes of Health-led ACTT-1 trial, a phase III trial that showed that patients with mild, moderate, and severe disease who were treated with up to 10 days of remdesivir recovered a median 5 days quicker than those on placebo (10 vs 15 days; rate ratio [RR] 1.29, 95% CI 1.12-1.49, P<0.001), and a median 7 days quicker in those requiring oxygen at baseline (11 vs 18 days; RR 1.31, 95% CI 1.12-1.52).

Fewer patients on oxygen at baseline progressed to mechanical ventilation or extracorporeal membrane oxygenation with remdesivir (13% vs 23%), and a trend toward lower day-29 mortality was observed with the drug (11.4% vs 15.2%; HR 0.73, 95% CI 0.52-1.03).

"The approval of Veklury marks an important milestone in efforts to help address the pandemic by offering an effective treatment that helps patients recover faster and, in turn, helps preserve scarce healthcare resources," ACTT-1 investigator Barry Zingman, MD, of the Albert Einstein College of Medicine and Montefiore Medical Center in New York City, said in a from drugmaker Gilead Sciences.

"The availability of a rigorously tested treatment that can significantly speed recovery and offers other benefits such as lower rates of progression to mechanical ventilation, provides hospitalized patients and their families important hope and offers healthcare providers a critical tool as they care for patients in need," added Zingman.

"Today's approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic," said FDA Commissioner Stephen Hahn, MD, in the agency's announcement.

Other trials that supported approval showed that a 5-day course of the drug was roughly equivalent to a 10-day course, and that some clinical benefit was also seen in patients hospitalized with moderate illness.

Remdesivir is contraindicated in those allergic to the drug or any of its components. Adverse events that were more common with the drug versus placebo included nausea and increased liver enzymes, but FDA listed other possible side effects that included allergic reactions, low blood oxygen level, fever, shortness of breath, wheezing, swelling, rash, nausea, sweating, and shivering.

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