Koselugo: which tox species, and why?

“The Applicant evaluated the toxicity profile of selumetinib in rats, mice, and monkeys in GLP-compliant studies with durations of up to 3 months (rats) and 26 weeks (mice and monkeys).”

“The Applicant chose the mouse as the rodent species for the long-term toxicology and developmental studies due to detectable levels of the active N-desmethyl metabolite in this species that allowed for toxicological coverage;”

“Administration of selumetinib to monkeys for up to 26 weeks was associated with loose/liquid feces, seen at 1.5 mg/kg BID in females and 4 mg/kg BID in males.”