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Reports of acute kidney injury in some patients with COVID-19 receiving remdesivir (Veklury, Gilead Sciences) have prompted the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) to launch a safety review.
Remdesivir has been granted conditional marketing authorization in Europe for the treatment of COVID-19 in adults and adolescents aged 12 years and older with pneumonia who require supplemental oxygen.
“The benefits to these severely ill patients outweigh the risks of making the medicine available despite having less complete data than normally expected,” the agency said in a statement.
Renal toxicity is noted in the Gilead’s risk management plan as “an important potential risk where further information was needed to better understand the effects of remdesivir on the kidney,” the EMA said.
When conditional marketing authorization was granted in Europe, renal toxicity was