EMA's PRAC reviews a safety signal with Veklury in COVID-19 patients

The European Medicines Agency’s Pharmacovigilance Risk Assessment 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).

Gilead Sciences’ (Nasdaq: GILD) repurposed anti-viral Veklury has been given a ‘conditional marketing authorization’ in the European Union 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.