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

“A standard Ames test was negative. A full genotoxicity test battery and carcinogenicity evaluation have not been conducted for omalizumab, due to the absence of a relevant species appropriate for such studies.”

“No carcinogenicity study with omalizumab was performed since omalizumab does not bind rodent IgE.”

“at doses of 0, 3, 15 and 75 mg/kg once daily on Days 20-22, and then once weekly through Day 50 did not elicit maternal toxicity, embryotoxicity or teratogenicity.”

“Safety parameters were monitored at regular intervals in the 4-week and 6-month monkey toxicology studies. These parameters included vital functions such as blood pressure, electrocardiograph measurements, heart rate and respiration rate.”