Cabenuva: which tox species, and why?

“Pivotal repeat-dose toxicology evaluations for CAB included GLP studies of up to 26 weeks duration in rats and 39 weeks duration in monkeys.”

“The test species were justified as the rodent and non-rodent species with the highest systemic exposure. All selected species are considered relevant from a metabolite perspective.”

“All studies were conducted using the oral formulation of CAB, with the exception of a 3-month bridging study in rats using the subcutaneous and IM routes.”

“Pivotal repeat-dose toxicology evaluations for CAB included GLP studies of up to 26 weeks duration in rats and 39 weeks duration in monkeys. Additional GLP studies of up to 13 weeks duration were conducted in mice to support the 2-year mouse carcinogenicity study.”

“Reproductive toxicology studies with CAB consist of a male fertility study in rats, a combined female fertility and embryo-fetal development study in rats, an embryo-fetal development study in rabbits, and PPND studies in rats.”

“Two-year carcinogenicity studies in mice and rats were conducted with cabotegravir.”