“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)”
✓ VerifiedFDA multi-discipline review, p. 39Source ↗
Why that species
Used previously for other JAK inhibitors and sensitive to the pharmacology of JAK inhibition
“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.”
✓ VerifiedFDA multi-discipline review, p. 39Source ↗