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CHMP Adopts Positive Opinion to Extend the Use of Veklury® (Remdesivir) to Treat COVID-19 in People With Severe Renal Impairment, Including Those on Dialysis

Published: 2023-05-26 05:00:00 ET

– If Granted by the European Commission, Veklury will become the First and Only Authorized Antiviral Treatment Across All Stages of Renal Disease –

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted a positive opinion for the use of Veklury® (remdesivir) in COVID-19 patients with severe renal impairment, including those on dialysis. The European Commission (EC) will review the CHMP recommendation and, if adopted, Veklury will become the first and only authorized antiviral COVID-19 treatment that can be used across all stages of renal disease.

In Europe, approximately 75 million people suffer from chronic kidney disease (CKD). Patients with advanced CKD or end stage kidney disease (ESKD) represent a population that is highly vulnerable to COVID-19. They are at increased risk of morbidity and mortality from COVID-19, with mortality rates as high as 21-25%, and currently have limited treatment options that are safe and effective.

“COVID-19 continues to pose a threat to the lives of vulnerable individuals, including those with renal impairment,” said Anu Osinusi, Vice President, Clinical Research for Hepatitis, Respiratory and Emerging Viruses, Gilead Sciences. “Gilead’s commitment to address the unmet needs of the most susceptible populations remains a top priority. We are encouraged by today’s CHMP opinion and will continue to invest in developing suitable treatment options for populations at risk of severe disease.”

The clinical benefit of Veklury in hospitalized populations with COVID-19 is supported by randomized controlled trials, real-world evidence and meta-analyses, but its use has previously been restricted among patients with severe renal impairment (

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All statements made via social media sites sponsored or maintained by Enhanced Investments and its affiliates are for informational purposes only and do not constitute a comprehensive description of Enhanced Investments' investment advisory services.
Certain investments are not suitable for all investors. Before investing, consider your investment objectives and applicable fees. The rate of return on investments can vary widely over time, especially for long term investments. Investment losses are possible, including the potential loss of all amounts invested. Information provided by Enhanced Investments is for informational and general educational purposes only and is not investment or financial advice.