Enspryng: which tox species, and why?

“The pivotal studies were conducted in cynomolgus monkey, the only pharmacologically relevant species.”

“Satralizumab showed cross-reactivity in cynomolgus monkey but not in mice or rats. Based on these data, monkey was selected as the relevant species for nonclinical testing of satralizumab.”

“Carcinogenicity studies of satralizumab were not conducted because satralizumab does not bind to rat or mouse IL-6R, and the use of a mouse homolog antibody was determined not to be feasible because of immunogenicity.”

“The pivotal studies were conducted in cynomolgus monkey, the only pharmacologically relevant species.”

“In the ePPND study, administration of satralizumab (0, 2, and 50 mg/kg/week SC) to pregnant females resulted in a dose-dependent reduction in the antibody responses to antigenic challenge in infants.”

“Carcinogenicity studies of satralizumab were not conducted because satralizumab does not bind to rat or mouse IL-6R, and the use of a mouse homolog antibody was determined not to be feasible because of immunogenicity.”

“Carcinogenicity studies of satralizumab were not conducted because satralizumab does not bind to rat or mouse IL-6R, and the use of a mouse homolog antibody was determined not to be feasible because of immunogenicity.”