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

“Not conducted, in line with ICH S6(R1).”

“In general, an overview of the published literature supports that neutralization of IL-23 would not be expected to increase cancer risk, but rather IL-23 increases tumor incidence and promotes tumor growth and progression.”

“However, incidences of embryo/fetal loss were higher in the treated groups compared to control (6.7% [1 of 15] in controls vs 26.7% [4 of 15] at 300 mg/kg) but were within the range of historical control data.”

“No adverse cardiovascular, central nervous system, or respiratory findings were observed in monkeys as part of the 4-week toxicology study administered via both IV (doses up to 100 mg/kg) and SC (doses up to 30 mg/kg) routes.”