Cibinqo: which tox species, and why?

“Oral repeat dose toxicity studies in rats (up to 6 months in duration); oral repeat dose toxicity studies in monkeys (up to 9 months in duration)”

“rats and monkeys were used for the general toxicology programme, as these species have previously been used in development programmes for other similar JAK inhibitors and they are sensitive to the pharmacological action of JAK inhibition.”

“In a pivotal 6-month oral repeat dose toxicity study in rats, abrocitinib (doses: 0, 30, 45, and 70 mg/kg/day) decreased lymphocytes at all dose levels consistent with its intended pharmacological effect.”

“Oral repeat dose toxicity studies in rats (up to 6 months in duration); oral repeat dose toxicity studies in monkeys (up to 9 months in duration)”

“fertility and early embryonic development studies in rats; embryofetal development studies in rats and rabbits; a pre- and postnatal development study in rats; and a juvenile animal toxicity study in rats.”

“Carcinogenicity studies were conducted in mice (6-month study in Tg rasH2 mice) and rats (104-week study).”

“According to the applicant, rats and monkeys were used for the general toxicology programme, as these species have previously been used in development programmes for other similar JAK inhibitors and they are sensitive to the pharmacological action of JAK inhibition.”