EMA's PRAC concludes Veklury is not associated with kidney problems

12 February 2021

The Pharmacovigilance Risk Assessment Committee (PRAC), a unit of the European Medicines Agency, has concluded its review of a safety signal to assess reports of acute kidney injury (AKI) in patients with COVID-19 treated with Veklury (remdesivir).

Veklury is a re-purposed antiviral from US biotech Gilead Sciences (Nasdaq: GILD) that, in its now approved use for the treatment of COVID-19 patients requiring hospitalization, generated revenues of $1.9 billion in the fourth quarter, and $2.8 billion over the full year 2020 for the company.

The PRAC assessed all available information, including data provided by the marketing authorization holder, analysis of reported adverse reactions, data from clinical trials and published scientific literature. After taking all the data into consideration, the PRAC concluded that currently there is no evidence indicating that the reported kidney problems are associated with the use of Veklury.

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