Gilead Sciences has announced that its COVID-19 treatment, Veklury (remdesivir), has been approved by the US Food and Drug Administration (FDA) to treat patients with severe renal impairment, including those on dialysis.

The drug is already approved in the US to treat COVID-19 in adults and paediatric patients who are hospitalised or have mild-to-moderate COVID-19 and are at high risk for progression to severe illness. However, its use has previously been limited among patients with severe renal impairment due to insufficient data.

The FDA’s latest decision makes Veklury the first and only approved antiviral COVID-19 treatment that can be used across all stages of renal disease.

Gilead’s supplemental new drug application was supported by positive results from a phase 1 study as well as data from the phase 3 REDPINE trial that demonstrated the efficacy and safety profile of Veklury among patients with moderately and severely reduced kidney function who were hospitalised for COVID-19.

Anu Osinusi, vice president, clinical research for hepatitis, respiratory, and emerging viruses at Gilead, said: “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.”

More than 37 million people in the US are estimated to have chronic kidney disease (CKD), a long-term condition characterised by a gradual loss of kidney function. End-stage kidney disease (ESKD) occurs when CKD reaches an advanced state.

“Patients with advanced CKD and ESKD are at high risk for severe COVID-19 with hospitalisation and mortality rates remaining high, even for those who are vaccinated,” explained Meghan Sise, department of nephrology at Massachusetts General Hospital, US.

“This latest update to the prescribing information for [Veklury] 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,” Sise said.

The US approval comes less than a month after the European Commission also extended the approved use of Veklury to treat COVID-19 in people with severe renal impairment, including those on dialysis.

Source: pmlive.com