Aimovig: which tox species, and why?

“The pivotal, GLP-compliant toxicology studies were conducted in cynomolgus monkey, the only biologically relevant species”

“Erenumab has high affinity for the monkey and human CGRP-R, but not for rodent CGRP-R or closely related CGRP-R family members.”

“General toxicology studies were conducted exclusively in monkeys, due to a lack of pharmacological activity in other species.”

“General toxicology studies were conducted exclusively in monkeys, due to a lack of pharmacological activity in other species.”

“The reproductive and developmental toxicology package consisted of a single enhanced PPND study in monkey, with dosing at 0 and 50 mg/kg”

“Carcinogenicity studies were waived, based on the lack of erenumab activity in rodents, histopathological data from the submitted toxicology studies showing no carcinogenic risk factors (i.e. hyperplasia or neoplasia)”

“General toxicology studies were conducted exclusively in monkeys, due to a lack of pharmacological activity in other species.”