Repatha: which tox species, and why?

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

“Evolocumab binds to human, cynomolgus monkey and hamster PCSK9 with high affinity (KD = 16, 8 and 14 pM, respectively; see Table 2).”

“Evolocumab is pharmacological active in human, Cynomolgous monkey and hamster. The latter two were used in toxicology studies, where also the pharmacodynamics parameters were measured.”