FDA approves Gilead’s Veklury for COVID-19 patients with severe renal impairment

Gilead Sciences said that the US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Veklury (remdesivir) usage in COVID-19 patients with severe renal impairment, encompassing those on dialysis.

This approval positions Veklury as the sole antiviral COVID-19 treatment approved for use in all stages of renal disease. It’s estimated that over 37 million people in the U.S., more than 1 in 7, suffer from chronic kidney disease (CKD) and are more susceptible to COVID-19 related morbidity and mortality. The U.S. approval follows the European Commission’s recent decision to broaden the approved use of Veklury for treating COVID-19 in people with severe renal impairment, including those on dialysis, as of June 26, 2023.

The revised prescribing guidelines for Veklury eliminate the need for dose adjustments in patients with renal impairment and eradicate the prerequisite for eGFR testing before or during treatment with Veklury. The clinical benefit of Veklury for hospitalized COVID-19 patients is substantiated by randomized controlled trials, real-world evidence, and meta-analyses. However, the drug’s usage has been restricted in patients with severe renal impairment due to a lack of sufficient data.

The FDA’s approval for Veklury’s use in these patients is based on findings from a Phase 1 study (GS-US-540-9015), alongside results from the Phase 3 REDPINE trial, which revealed the pharmacokinetics (PK) and safety profile of Veklury in this demographic. No new safety concerns were detected in either study.

“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,” stated Anu Osinusi, Vice President, Clinical Research for Hepatitis, Respiratory and Emerging Viruses at Gilead Sciences. “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 3 kg) who are either hospitalized or at high risk for progression to severe COVID-19, including hospitalization or death. It is contraindicated in patients allergic to Veklury or any of its components.