FDA Approves Gilead's Veklury For COVID-19 Treatment In Patients With Severe Renal Impairment

(RTTNews) - The U.S. Food and Drug Administration approved a supplemental new drug application or sNDA for the use of Veklury or remdesivir in COVID-19 patients with severe renal impairment, including those on dialysis, Gilead Sciences Inc. (GILD) said in a statement.

Veklury is now the first and only approved antiviral COVID-19 treatment that can be used across all stages of renal disease, the company said.

The U.S. approval comes on the heels of the European Commission decision to extend the approved use of Veklury to treat COVID-19 in people with severe renal impairment, including those on dialysis, which was adopted on June 26, 2023.

In the United States, Veklury is indicated for the treatment of COVID-19 in adults and pediatric patients (28 days and older and weighing at least 3 kg) who are either hospitalized, or not hospitalized and are at high risk for progression to severe COVID-19, including hospitalization or death.

Gilead noted that Veklury is approved in more than 50 countries worldwide. To date, Veklury and generic remdesivir have been made available to more than 13 million patients around the world, including more than 8 million people in middle- and low-income countries through Gilead's voluntary licensing program.

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