L’EMA a déclaré aujourd’hui, dans un communiqué, que le Comité d’Évaluation des risques en matière de pharmacovigilance du 28 septembre – 1er octobre 2020 (PRAC) examine les rapports concernant des lésions rénales aiguës chez certains patients atteints de COVID-19 traités avec le médicament antiviral remdesivir. Vous trouverez ci-dessous la dépêche de l’EMA sur Remdesivir et risque de lésion rénale aiguë.
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September – 1 October 2020
« The EMA said in a statement today that its safety committee is reviewing reports of acute kidney injury in some patients with COVID-19 who were being treated with the antiviral drug remdesivir. The EMA had conditionally approved the drug for treatment of COVID-19 in those ages 12 and older with pneumonia who require supplemental oxygen.
When Gilead, the maker of remdesivir, applied for marketing authorization, it had evaluated renal toxicity in animals with the understanding that more information was needed to better understand the impact of the drug on kidneys. The EMA said so far there’s no causal link between the drug and reports of acute kidney injury, which can result from other factors such as diabetes and COVID-19 infection. »