“Toxicity studies with idarucizumab were performed in rats and rhesus monkeys. All studies in monkeys were conducted in the absence and presence of DE.”
Target is dabigatran: rhesus chosen as dabigatran half-life is similar to humans and rhesus form its active glucuronides; rats do not
“Dabigatran half-life of dabigatran is similar in rhesus and humans, while it is much shorter in rats. Furthermore, rhesus monkeys generate the active glucuronide metabolites of dabigatran, whereas in rats this is negligible.”
No surrogate; the clinical Fab was tested in rats and rhesus monkeys, with and without dabigatran etexilate
“Toxicity studies with idarucizumab were performed in rats and rhesus monkeys. All studies in monkeys were conducted in the absence and presence of DE.”