Praluent: which tox species, and why?

“The Applicant identified the rat and monkey as pharmacologically relevant species for toxicology testing with alirocumab; both species express PCSK9, to which alirocumab binds with high affinity.”

“Alirocumab was shown to bind human and Cynomolgus monkey PCSK 9 with comparable affinity and lower affinity, but in nanomolar range to mouse, hamster, and rat PCSK9.”

“Repeat dose toxicity studies were conducted in rats and Cynomolgus monkeys.”