The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a safety review to assess reports of acute kidney injury in some patients with COVID-19 taking remdesivir (Veklury).
Remdesivir has been given conditional marketing authorisation in the EU for the treatment of COVID-19 in adults and adolescents ≥12 years of age with pneumonia requiring supplemental oxygen.
Renal toxicity was evaluated at the time of the marketing authorisation application, primarily on the basis of animal studies. It was highlighted in the risk management plan as an important potential risk where further information was needed to better understand the effects of remdesivir on the kidney. Enhanced safety monitoring is in place to pick up reports of unwanted effects and acute kidney injury is being followed as an adverse event of special interest (AESI) in monthly summary safety reports for remdesivir.
At this point, it has not been determined whether there is a causal relationship between the drug and the reports of acute kidney injury.
The PRAC will now assess all available data to determine if the medicine may have been responsible for the kidney injury and if there is a need to update the existing information for remdesivir.