FDA approves Veklury for COVID-19 treatment in patients with severe renal impairment
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Key takeaways:
- Veklury is indicated for the treatment of COVID-19 in adult and pediatric patients in the United States.
- Approval was based on the phase 1 and phase 3 REDPINE trials.
The FDA has approved the use of Veklury for the treatment of COVID-19 in patients with severe renal impairment, including those on dialysis, according to a press release from drug manufacturer Gilead Sciences Inc.
“Patients with advanced [chronic kidney disease] CKD and end-stage kidney disease are at high risk for severe COVID-19 with hospitalization and mortality rates remaining high, even for those who are vaccinated,” Meghan Sise, MD, of the department of nephrology at Massachusetts General Hospital, said in the release. “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.”
Updated prescribing information for Veklury (remdesivir) states dose adjustments are not required for renal-impaired patients and eGFR testing is not required before or during treatment, according to the release. Gilead said approval was based on the phase 1 and phase 3 REDPINE trials, which showed the pharmacokinetics and safety profile of the drug in patients with severe renal impairment. It is now the only antiviral treatment approved for COVID-19 for use at any stage of renal disease, according to the company.
The drug is indicated for the treatment of COVID-19 in adults and pediatric patients in the United States, who are either hospitalized or at high risk for progression to severe COVID-19. It has shown promising results in reducing the duration of hospitalization and improving clinical outcomes in patients with severe COVID-19, according to the company.
“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,” Anu Osinusi, vice president of clinical research for hepatitis, respiratory and emerging viruses at Gilead Sciences, said in the release. “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.”
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