Gilead’s Remdesivir (Veklury) to Be Reviewed by EU Regulator After COVID-19 Patients Report Acute Kidney Injury

The European Medicines Agency’s safety committee (PRAC) has begun a review of a safety signal to assess reports of acute kidney injury in some COVID-19 patients who were taking Gilead Sciences’ (Foster City, CA, USA) antiviral drug Veklury (remdesivir).

Remdesivir is being studied in multiple ongoing international clinical trials and has been approved by multiple regulatory authorities around the world, including in the European Union (EU) and Japan. Remdesivir had been granted an Emergency Use Authorization (EUA) in the US for the treatment of hospitalized patients with severe COVID-19, which was defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator. Recently, the FDA had revised the EUA to expand the scope of the authorized uses of remdesivir to include the treatment of hospitalized adult and pediatric patients, irrespective of their disease severity.

In the EU, Veklury has been given a ‘conditional marketing authorization’ 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-authorization phase.

For Veklury, renal toxicity was evaluated at the time of the marketing authorization 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.

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.

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