Ajovy: which tox species, and why?

“Because the shorter duration studies in rat and monkey demonstrated no toxicity, the chronic study was conducted only in cynomolgus monkey.”

“Fremanezumab is pharmacologically active in rat, rabbit, monkey, and human, as characterized in a series of binding and functional in vitro assays.”

“General toxicology studies were conducted in rat and cynomolgus monkeys. In general, fremanezumab was well tolerated, with no significant adverse effects in either species.”

“The pivotal (GLP) toxicity studies were conducted in Sprague-Dawley rat (1- and 3-month) and cynomolgus monkey (1-, 3-, and 6-month).”

“Reproductive and developmental toxicity was assessed in a fertility + EFD study in rats, a EFD study in rabbits and a PPND study in rats.”

“Based on published studies in CGRP knockout animals and on the biological activity of CGRP (e.g., promotion of angiogenesis) and on the results from the sponsor’s studies of fremanezumab, it was concluded that standard carcinogenicity studies of fremanezumab were not needed.”

“Fremanezumab is pharmacologically active in rat, rabbit, monkey, and human, as characterized in a series of binding and functional in vitro assays.”