PRAC reviews a signal with Veklury

EMA’s safety committee (PRAC) has started a review of a safety signal to assess reports of acute  kidney injury in some patients with COVID-19 taking Veklury (remdesivir).

Veklury has been given a ‘conditional marketing authorisation’ in the EU for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen, because the benefits to these severely ill patients outweigh the risks of making the medicine available despite having less complete data than normally expected. This means that more evidence is required to be submitted in the post-authorisation phase.

For Veklury, 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 stage, it has not been determined whether there is a causal relationship between Veklury 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.

Kidney injury can be caused by other factors as well, e.g. diabetes; importantly, COVID-19 is itself known to be a cause. The PRAC will now carefully assess all available data to evaluate if the medicine may have been responsible for the kidney problems and if there is a need to update the existing information for Veklury. Recommendations for the use of this medicine have not changed. The product information already advises doctors to monitor patients for renal impairment prior to and during treatment and not start treatment in patients with an important decrease in renal function.

The PRAC has started this review based on the results from continuous signal detection work undertaken in EudraVigilance.

EMA is reviewing any new information that becomes available through monthly summary safety reports (a tool for enhanced safety monitoring), periodic safety update reports and signal detection.

In cases where a causal relationship is confirmed or considered likely, regulatory action may be necessary and this usually takes the form of an update of the summary of product characteristics and the package leaflet. EMA will further communicate on the outcome of the PRAC’s review.

Posted on the EMA website on 2 October 2020