PRAC 👮initiated a review on safety signal to assess reports of acute kidney injury in some patients with COVID-19 taking Veklury (remdesivir).
The PRAC has started this review based on the results from continuous signal detection work undertaken in EudraVigilance.
Veklury has given "conditional marketing approval" in the EU for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen.
A "conditional marketing approval" means more evidence required to be submitted in post-authorisation phase.
At the time of marketing authorisation application, renal toxicity was evaluated based upon animal studies and this was reflected as an important potential risk in the Risk Management Plan (RMP). This means further information required for better understanding of the effects of remdesivir on the kidney.
The provision of additional monitoring 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.
According to EMA, it has not been determined whether there is a causal relationship between Veklury and the reports of acute kidney injury.
The PRAC will 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.
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.
Ref📚: EMA- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September - 1 October 2020