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.”

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

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

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

“Conventional rodent carcinogenicity studies were not conducted for the evaluation of the carcinogenic potential of mirikizumab as rodents are not a pharmacologically relevant species.”

“Concurrence has been received from the Executive Carcinogenicity Assessment Committee of CDER that a 2-year rodent carcinogenicity study is not needed.”

“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.”