Vyepti: which tox species, and why?

“Toxicity studies with eptinezumab were conducted in rats, cynomolgus monkeys and rabbits. These species are considered pharmacologically relevant based on the affinity and functional activity of eptinezumab against CGRP from these species.”

“Eptinezumab has high affinity and specificity for rat, rabbit, monkey, and human α- and β-CGRP without off target binding to amylin, calcitonin, adrenomedulin, or intermedin/ adrenomedulin-2.”

“Toxicity studies with eptinezumab were conducted in rats, cynomolgus monkeys and rabbits.”

“General toxicity of eptinezumab was evaluated in single-dose and repeat-dose studies in rats and cynomolgus monkeys. Short-term studies (up to 28 days) were conducted in both species while the chronic toxicity was evaluated in cynomolgus only.”

“A standard battery of reproductive and developmental toxicology studies was conducted in Sprague-Dawley rat (fertility and early embryonic development, embryofetal development (EFD), and pre- and postnatal development) and New Zealand White rabbit (EFD).”

“(A chronic toxicity study in a second species (rat) and rodent carcinogenicity studies were not required, primarily because of data demonstrating development of anti-drug antibodies in rat that precluded conduct of meaningful long-term studies.)”

“Toxicity studies with eptinezumab were conducted in rats, cynomolgus monkeys and rabbits. These species are considered pharmacologically relevant based on the affinity and functional activity of eptinezumab against CGRP from these species.”