PRAC Starts Safety Review of Remdesivir

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Reports of acute kidney injury in some patients with COVID-19 receiving remdesivir (Veklury, Gilead Sciences) have prompted the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) to launch a safety review.

Remdesivir has been granted conditional marketing authorization in Europe for the treatment of COVID-19 in adults and adolescents aged 12 years and older with pneumonia who require supplemental oxygen.

“The benefits to these severely ill patients outweigh the risks of making the medicine available despite having less complete data than normally expected,” the agency said in a statement.

Renal toxicity is noted in the Gilead’s risk management plan as “an important potential risk where further information was needed to better understand the effects of remdesivir on the kidney,” the EMA said.

When conditional marketing authorization was granted in Europe, renal toxicity was evaluated primarily on the basis of animal studies.

As a result, enhanced safety monitoring was put in place to detect reports of unwanted effects, with acute kidney injury, specifically, being followed as an “adverse event of special interest” in monthly summary safety reports for remdesivir.

Today, the agency announced that there have been reports of acute kidney injury in some patients on remdesivir.

“At this stage, it has not been determined whether there is a causal relationship between remdesivir and the reports of acute kidney injury. The reports form a ‘safety signal’ — information on a new or incompletely documented adverse event that is potentially caused by a medicine and that warrants further investigation,” the EMA said.

They note that other factors such as diabetes can cause kidney injury and “importantly,” COVID-19 is itself known to be a cause of acute kidney injury.

The PRAC will now assess all available data to evaluate if remdesivir may have been responsible for the kidney problems and if there is a need to update the existing information for the drug.

For now, recommendations for the use of remdesivir have not changed. The product information already advises healthcare providers to monitor patients for renal impairment prior to and during treatment and to not start treatment in patients with “an important decrease in renal function.”

Remdesivir also has emergency use authorization in the United States for all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of disease.

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