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

“No genotoxicity studies were performed with canakinumab, as it is a protein. This is acceptable according to guideline ICH S6.”

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

“Taken together the reproductive toxicity studies in marmosets and in mice did not identify a signal for reproductive toxicity by neutralization of IL-1b.”

“Stand-alone safety pharmacology studies were not conducted with canakinumab. However, the cardiovascular system was analyzed as part of the toxicology studies.”

“No genotoxicity studies were performed with canakinumab, as it is a protein. This is acceptable according to guideline ICH S6.”

“No genotoxicity studies were performed with canakinumab, as it is a protein. This is acceptable according to guideline ICH S6.”

“No genotoxicity studies were performed with canakinumab, as it is a protein. This is acceptable according to guideline ICH S6.”

“Since pro-inflammatory cytokines such as IL-1 are implicated in tumor development, neutralization of IL-1 is not expected to promote tumour development.”

“Also, the pharmacodynamics of canakinumab does not warrant carcinogenicity studies.”

“Stand-alone safety pharmacology studies were not conducted with canakinumab. However, the cardiovascular system was analyzed as part of the toxicology studies. No treatment-related effects on electrocardiography data were observed throughout treatment and recovery periods.”