Kevzara: which tox species, and why?

“Pivotal nonclinical studies of sarilumab were conducted in Cynomolgus monkeys by intravenous and SC dosing since only monkeys were identified as a relevant species for sarilumab in a series of pharmacology studies.”

“Sarilumab binds human and Cynomolgus monkey IL-6Rα with an equilibrium dissociation constant (Kd) of 54 pM and 123 pM, respectively, but no binding of sarilumab to the murine IL-6Rα was observed.”

“Fertility and juvenile toxicity studies were also conducted in mice with an analogous monoclonal antibody (REGN844).”

“Pivotal nonclinical studies of sarilumab were conducted in Cynomolgus monkeys by intravenous and SC dosing since only monkeys were identified as a relevant species for sarilumab in a series of pharmacology studies.”

“The reproductive and developmental toxicity of sarilumab was evaluated in an enhanced pre- and postnatal development (ePPND) study in cynomolgus monkeys. Further, a murine surrogate monoclonal antibody to sarilumab that binds mouse IL-6Rα (i.e., REGN844) was developed and used for a fertility study in mice.”

“Based on species specificity, a rodent carcinogenicity study with sarilumab was not considered feasible. The Executive Carcinogenicity Assessment Committee (ECAC) concurred that a carcinogenicity study was not feasible.”

“Fertility and juvenile toxicity studies were also conducted in mice with an analogous monoclonal antibody (REGN844).”