FDA Approves Gilead's Remdesivir For COVID-19 Treatment Patients With Severe Renal Impairment

The FDA approved Gilead Sciences Inc's GILD supplemental new drug application for using 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. 

More than 1 in 7 (37 million) people in the U.S. are estimated to have chronic kidney disease (CKD) and are at increased risk of COVID-19-related morbidity and mortality. 

The U.S. approval comes on the heels of the European Commission's 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 June 26, 2023.

Also Read: Gilead Sciences Touts Encouraging Data From Real-World Studies Of Its Flagship COVID-19 Treatment.

The updated prescribing information for Veklury does not require dose adjustments for renal-impaired patients and removes the requirement for eGFR testing before or during treatment with Veklury. 

The approval for use in patients with severe renal impairment was based on results from a Phase 1 study and from the Phase 3 REDPINE trial that demonstrated the pharmacokinetics (PK) and safety profile of Veklury in this population. 

No new safety signals were observed in either of the studies.

In the U.S., 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 not hospitalized and are at high risk for progression to severe COVID-19, including hospitalization or death. 

Price Action: GILD shares are up 0.64% at $77.20 on the last check Friday.

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