Uplizna: which tox species, and why?

“Therefore, toxicology studies were conducted using a transgenic mouse model expressing human CD19 (huCD19 Tg).”

“Inebilizumab binds specifically to human CD19 and shows no cross-reactivity for CD19 in nonhuman primate, rodents, or rabbits. Therefore, the species selected for nonclinical testing was the human CD19 transgenic mouse model (huCD19 Tg), which was considered the only relevant species.”

“The pivotal nonclinical studies were conducted in a transgenic mouse (hCD19Tg) model that expresses human CD19 because inebilizumab is not pharmacologically active in rodent (mouse, rat) or nonrodent (rabbit, monkey).”

“General toxicity studies of 4 weeks, 3 months, and 6 months’ duration were conducted using the huCD19Tg mouse model.”

“Two reproductive toxicology studies were conducted in the huCD19Tg mouse model: combined male and female fertility and embryofetal development study and a pre-and postnatal development study.”

“Carcinogenicity studies were not required, as agreed to by the Division (IND 117295, May 4, 2016).”

“The pivotal nonclinical studies were conducted in a transgenic mouse (hCD19Tg) model that expresses human CD19 because inebilizumab is not pharmacologically active in rodent (mouse, rat) or nonrodent (rabbit, monkey).”