Fasenra: genotox, carcinogenicity and repro: done or skipped?

“Genetic toxicity studies were not applicable for this therapeutic biologic protein.”

“Carcinogenicity studies were not conducted since rodents are not pharmacologically relevant species. AstraZeneca submitted a carcinogenicity risk assessment that was evaluated by the CDER Executive Carcinogenicity Assessment Committee.”

“Benralizumab was not teratogenic in cynomolgus monkeys. The NOAEL for maternal toxicity and teratogenicity was identified at 30 mg/kg.”

“These studies included assessment of potential effect of benralizumab on cardiovascular, respiratory and central nervous systems, following single and repeated subcutaneous and intravenous doses, up to 30 mg/kg. There was no indication of toxicity in these evaluations.”

“Genetic toxicity studies were not applicable for this therapeutic biologic protein.”

“Genetic toxicity studies were not applicable for this therapeutic biologic protein.”

“Genetic toxicity studies were not applicable for this therapeutic biologic protein.”

“Since benralizumab does not bind to murine IL-5Rα, direct assessment of carcinogenic risk of benralizumab in a classic 2-year rodent bioassay was not appropriate.”

“AstraZeneca submitted a carcinogenicity risk assessment that was evaluated by the CDER Executive Carcinogenicity Assessment Committee. The Committee agreed that a carcinogenicity study was not required.”

“There were no abnormal ECG findings in any animals on study.”