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Jan 31, 2024

FDA approves Veklury as first antiviral COVID

Press Release Press Release The FDA expanded its approval of Gilead Sciences’ antiviral, Veklury, for the treatment of COVID-19 in patients with mild, moderate and severe hepatic impairment, without

Press Release

Press Release

The FDA expanded its approval of Gilead Sciences’ antiviral, Veklury, for the treatment of COVID-19 in patients with mild, moderate and severe hepatic impairment, without requiring dose adjustments, according to a manufacturer release.

Gilead noted that this approval supports the safety profile of Veklury (remdesivir, Gilead Sciences) “as the first and only approved antiviral COVID-19 treatment that can be used across all stages of liver disease.” The FDA’s expanded indication of Veklury for hepatic impairment mirrors similar decisions made last month for extending approved use of the drug for patients with severe renal impairment.

“With the recent increase in levels of COVID-19 circulating in the U.S., the risk to vulnerable individuals persists, including for those with hepatic impairment,” Frank Duff, MD, senior vice president and head of the virology therapeutic area at Gilead Sciences, said in a press release. “This approval demonstrates Gilead’s ongoing commitment to COVID-19, including our focus on vulnerable populations.”

According to the company, remdesivir (100 mg injection) is indicated for the treatment of COVID-19 in adults and pediatric patients in the U.S., who are either hospitalized or not hospitalized, but have exhibited mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19.

The FDA based its decision on results from GS-US-540-9014, a phase 1, multicenter, open-label, single-dose study, which examined the safety and pharmacokinetics of remdesivir among patients with either normal hepatic function and moderate or severe hepatic impairment.

Based on study results that found “no new safety signals,” the FDA has updated prescribing information for Veklury to emphasize that no dose adjustment is required across all liver disease stages. However, the label still recommends hepatic laboratory testing for all patients prior to initiating treatment and during treatment as necessary. Additionally, the label noted that Veklury discontinuation should be considered if alanine transaminase levels increase up to 10 times the upper limit of ‘normal’ or if ALT elevation is observed along with liver inflammation symptoms.

“The update to the safety profile and dosing recommendations for Veklury for those living with liver disease is important to this vulnerable population who faces an increased risk of complications from COVID-19,” Douglas Dieterich, MD, director at the Institute for Liver Medicine in the Icahn School of Medicine at Mount Sinai, said in the release. “While COVID-19 is no longer a public health emergency, the virus continues to present a threat to those with underlying conditions.”