Remdesivir supplemental drug application for CKD patients approved by FDA

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Gilead Sciences has announced that the US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for the use of Veklury (remdesivir) in COVID-19 patients with severe renal impairment, including those on dialysis. With this approval, Veklury is now the first and only approved antiviral COVID-19 treatment that can be used across all stages of renal disease. The US 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 26 June 2023.

“Patients with advanced chronic kidney disease (CKD) and end-stage kidney disease (ESKD) are at high risk for severe COVID-19 with hospitalisation and mortality rates remaining high, even for those who are vaccinated. With limited clinical trial information for COVID-19 patients with advanced CKD and ESKD, few antiviral treatment options currently exist for this population,” said Meghan Sise (Massachusetts General Hospital, Boston, USA). “This latest update to the prescribing information for remdesivir now includes patients with advanced CKD and ESKD and this is an important advance for a population that remains highly vulnerable to the impacts of COVID-19.”

The updated prescribing information for Veklury does not require dose adjustments for renally-impaired patients and removes the requirement for eGFR testing before or during treatment with Veklury. The clinical benefit of Veklury in hospitalised patients with COVID-19 is supported by randomised controlled trials (RCTs), real-world evidence and meta-analyses, states a Gilead press release, but its use “has previously been limited among patients with severe renal impairment due to insufficient data”.

This approval for use in patients with severe renal impairment was based on results from a Phase 1 studyas well as results from the Phase 3 REDPINE trial that demonstrated the pharmacokinetics and safety profile of Veklury in this population, the press release adds. No new safety signals were observed in either of the studies.

“The approval by the FDA of Veklury for the treatment of patients with renal impairment reflects the urgency to make this medicine available to these patients, and underscores the established safety profile for Veklury,” said Anu Osinusi of Gilead Sciences (Foster City, USA). “Gilead is committed to discovering, developing and providing transformational therapies for COVID-19, including for the most vulnerable populations at risk of developing severe disease.”

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 3kg) who are either hospitalised, or not hospitalised and are at high risk for progression to severe COVID-19, including hospitalisation or death. The press release concludes by noting that Veklury is contraindicated in patients who are allergic to Veklury or any of its components.

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