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

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

“The need for a carcinogenicity study was discussed with the Executive Carcinogenicity Assessment Committee and it was concluded that a carcinogenicity study was not required given the lack of related findings in the 6-month toxicology study in monkeys and since conduct of a study in rodents did not appear to be technically feasible.”

“No effects on fertility or development parameters were identified in monkeys at doses up to 100 mg/kg IV; exposure margins of approximately 70-fold and 30-fold were available for fertility and developmental parameters, respectively. Similarly, no effects on fertility or embryofetal development parameters were identified in mice treated with the surrogate antibody.”

“Mepolizumab at single intravenous doses up to 100 mg/kg had no effects on mean arterial pressure, heart rate, respiratory rate, urinary pH and water, osmolality, sodium, potassium, chloride, and creatinine excretion rates.”