Vafseo: which risks did reviewers probe?

“It is considered acceptable that no information has been submitted on immunotoxicity as no relevant findings have been observed in the repeat-dose toxicity studies in rats and dogs to indicate an immunotoxic potential.”

“Administered to pregnant rats and lactating rats, vadadustat related compounds were detected in the fetal tissues and the milk, demonstrating that vadadustat can cross placental tissues and can be delivered to newborns via nursing.”

“In brief, several signals were detected that were considered relevant for translation to human administration, i.e. pharmacologically exaggerated toxicities such as polycythemia/hyperviscosity which resulted in fibrin thrombosis and mortalities at clinically relevant dose levels as well as heart valvular findings.”