The US Food and Drug Administration (FDA) has approved the use of Gilead’s Veklury (remdesivir) in Covid-19 patients with severe renal impairment, making it the sole antiviral allowed in all stages of kidney disease.

This latest approval allows the use of Veklury for patients on dialysis, per the 14 July announcement.

In May, the European Medicines Agency’s (EMA) Committee for Medicinal products for Human Use (CHMP) adopted a positive opinion to extend the use of the drug in this patient subset, moving the decision to the European Commission (EC).

The FDA approval is based on clinical data that includes results from the Phase III REDPINE trial (NCT04745351), which highlighted the drug’s safety profile in patients with severe renal impairment. The updated use will not require any dose adjustment for these patients, and negates the required estimated glomerular filtration rate (eGFR) testing pre or during treatment with the drug, according to the announcement.  

Approximately 37 million people in the US have chronic kidney disease, putting them at greater risk of Covid-19-related morbidity and mortality. Gilead estimates that roughly 75 million people in Europe suffer from the same condition, based on the 26 May press release.

The SARS-CoV-2 nucleotide analogue RNA polymerase inhibitor first received an emergency use authorisation (EUA) for treating hospitalised patients with Covid-19 in May 2020. A few months later, the FDA granted full approval for use in adult and paediatric patients aged 12 years and above. The drug’s use has since been further expanded, with the FDA approving its use in non-hospitalised patients at high risk for Covid-19 disease progression in January 2022. The same agency also approved antiviral use in paediatric patients younger than 12 in April 2022.

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Notably, other Covid-19 antivirals such as Pfizer’s Paxlovid are not recommended for use in patients with severe renal impairment and end-stage renal disease, per the drug’s label. Paxlovid is a combination of the antiviral drugs nirmatrelvir and ritonavir.

While GSK’s monoclonal antibody sotrovimab previously received an EUA, this has since been withdrawn in the US. In February 2023, the UK’s National Institute for Health Excellence (NICE) recommended its use in at-risk patients with Covid-19 as part of its final draft guidance. This move was welcomed by organisations such as Kidney Research UK, as kidney disease patients could not use Paxlovid.

Based on GlobalData’s Pharma Intelligence Centre sales consensus forecasts, Veklury is predicted to have global sales of $805 million in 2029. The platform predicts that Paxlovid will save global sales of over $6 billion in the same year.

GlobalData is the parent company of Pharmaceutical Technology.