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

“No genetic toxicology studies were conducted.”

“Nipocalimab is a mAb which does not cross-react with rodent FcRn, precluding the conduct of traditional carcinogenicity studies. In line with ICH guideline S6(R1) and based on a WoE approach it was concluded that nipocalimab does not pose an increased carcinogenic risk.”

“These infarcts were associated with fetal loss (one stillborn fetus) at 100 mg/kg and 300 mg/kg (two aborted fetuses).”

“Safety pharmacology assessments were incorporated into the 4-week and 26-week IV toxicity studies in monkey; there were no effects of nipocalimab on cardiovascular, respiratory, or central nervous system parameters.”

“No genetic toxicology studies were conducted.”

“No genetic toxicology studies were conducted.”

“No genetic toxicology studies were conducted.”

“Nipocalimab is not pharmacologically active in mouse or rat; therefore, carcinogenicity studies were not conducted.”

“Overall, the carcinogenic potential has been adequately addressed and it is considered that the WoE submitted by the applicant lends support to the conclusion that the carcinogenic potential of nipocalimab is unlikely.”

“Safety pharmacology assessments were incorporated into the 4-week and 26-week IV toxicity studies in monkey; there were no effects of nipocalimab on cardiovascular, respiratory, or central nervous system parameters.”