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FDA Approves Veklury® (Remdesivir) for Treatment of COVID-19 in Patients With Severe Renal Impairment, Including Those on Dialysis

Saturday, July 15, 2023

Gilead Sciences has announced that the U.S. Food and Drug Administration (FDA) has approved the use of Veklury® (remdesivir) for COVID-19 patients with severe renal impairment, including those undergoing dialysis. This approval makes Veklury the first and only antiviral treatment for COVID-19 that is authorized across all stages of renal disease. It is estimated that more than 1 in 7 people (37 million) in the U.S. have chronic kidney disease (CKD) and are at a higher risk of COVID-19-related complications and mortality.

The FDA approval in the U.S. follows a similar decision by the European Commission on June 26, 2023, to extend the approved use of Veklury for treating COVID-19 in individuals with severe renal impairment, including dialysis patients.

Patients with advanced CKD and end-stage kidney disease (ESKD) are particularly vulnerable to severe COVID-19, with high hospitalization and mortality rates, even among those who are vaccinated. Currently, there are limited treatment options available for this population, as there is limited clinical trial data specifically for COVID-19 patients with advanced CKD and ESKD.

The updated prescribing information for Veklury removes the need for dose adjustments in patients with renal impairment and eliminates the requirement for estimated glomerular filtration rate (eGFR) testing before or during treatment. The clinical benefits of Veklury in hospitalized COVID-19 patients are supported by randomized controlled trials, real-world evidence, and meta-analyses. However, its use has been limited in patients with severe renal impairment due to insufficient data.

The FDA approval for the use of Veklury in patients with severe renal impairment is based on the results of a Phase 1 study (GS-US-540-9015) and the Phase 3 REDPINE trial, which demonstrated the pharmacokinetics (PK) and safety profile of Veklury in this specific patient population. No new safety concerns were observed in either study.

This FDA approval highlights the need to make Veklury available to patients with renal impairment and underscores its established safety profile. In the United States, Veklury is indicated for the treatment of COVID-19 in adults and pediatric patients (28 days and older, weighing at least 3 kg) who are either hospitalized or at high risk of disease progression to severe COVID-19, including hospitalization or death. Veklury is contraindicated in individuals with known allergies to Veklury or any of its components.

Veklury (remdesivir) is a nucleotide analog developed by Gilead Sciences based on their extensive antiviral research. It is considered the standard of care for the treatment of hospitalized COVID-19 patients and is recommended for reducing disease progression in non-hospitalized individuals at high risk. Veklury has a well-established safety profile and minimal known drug interactions across diverse populations. It plays a crucial role in reducing disease progression, mortality, and facilitating faster recovery across various disease severities.



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