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

“Genetic toxicology studies were not conducted because, as a monoclonal antibody, DAC HYP is not expected to interact directly with DNA.”

“Because DAC HYP is pharmacologically active only in monkey, carcinogenicity studies are not feasible; therefore, the carcinogenic potential of DAC HYP was not assessed.”

“Once-weekly SC dosing with 50 mg/kg DAC-HYP during gestation days (GD) 50-160 did not affect pre- or postnatal development. However, once-weekly SC administration of 200 mg/kg DAC-HYP administered during the first 5 weeks of pregnancy increased the incidence of fetal loss.”

“Safety pharmacology of daclizumab was performed in cynomolgus monkeys (Macaca fascicularis), by subcutaneous administration. Overall studies showed a good safety profile.”

“Genetic toxicology studies were not conducted because, as a monoclonal antibody, DAC HYP is not expected to interact directly with DNA.”

“Genetic toxicology studies were not conducted because, as a monoclonal antibody, DAC HYP is not expected to interact directly with DNA.”

“Genetic toxicology studies were not conducted because, as a monoclonal antibody, DAC HYP is not expected to interact directly with DNA.”

“Because DAC HYP is pharmacologically active only in monkey, carcinogenicity studies are not feasible; therefore, the carcinogenic potential of DAC HYP was not assessed.”

“Because DAC HYP is pharmacologically active only in monkey, carcinogenicity studies are not feasible; therefore, the carcinogenic potential of DAC HYP was not assessed.”

“Examinations were performed twice during the prestudy phase, on Study Day 129 and Week 39, and on the recovery group animals. There were no ECG abnormalities.”