Fasenra: which tox species, and why?

“Pivotal nonclinical studies were conducted in Cynomolgus monkeys.”

“Benralizumab binds to human and cynomolgus monkey IL-5Rα with KD values of 11 and 42 pM, respectively (as measured by BIAcore). Benralizumab did not cross-react with murine IL-5Rα.”

“Further, the ECAC agreed that development of a mouse surrogate was not required.”

“Pivotal nonclinical studies were conducted in Cynomolgus monkeys. In toxicology studies up to 39 weeks duration, NOAELs of 10 mg/kg IV and 30 mg/kg SC were identified.”

“An enhanced pre- and post-natal development studies were conducted with cynomolgus monkeys to evaluate benralizumab’s effects on development.”

“Carcinogenicity studies were not conducted since rodents are not pharmacologically relevant species.”

“Further, the ECAC agreed that development of a mouse surrogate was not required.”