Ilaris: which tox species, and why?

“Toxicity of canakinumab was analysed in marmoset monkeys. Additional toxicity studies were conducted with the murine surrogate mAb 01BSUR in mice.”

“Canakinumab does not bind to IL-1β from mouse, rat, rabbit, or cynomolgus monkey. The only nonhuman species specifically recognized by canakinumab is the marmoset monkey.”

“In addition a full panel of reproductive toxicity studies was performed with the surrogate mAb 01BSUR in mice.”

“Toxicity of canakinumab was analysed in marmoset monkeys. Additional toxicity studies were conducted with the murine surrogate mAb 01BSUR in mice.”

“Reproductive toxicity studies in marmosets were limited to evaluation of male fertility (part of the 26 weeks repeat-dose toxicity study) and an embryo-fetal development study.”

“No carcinogenicity studies were performed with canakinumab. According to guideline ICH S6 carcinogenicity studies are generally not required for monoclonal antibodies.”

“In addition a full panel of reproductive toxicity studies was performed with the surrogate mAb 01BSUR in mice.”