“A 6-month SC and IV study in cynomolgus monkeys (once weekly dosing) represented the pivotal toxicology study to support the marketing approval of tezepelumab.”
✓ VerifiedFDA multi-discipline review, p. 33Source ↗
Pivotal GLP studies
4 GLP cynomolgus monkey repeat-dose studies of up to 6 months
“The tezepelumab non-clinical safety package included 4 GLP cynomolgus monkey repeat-dose toxicology studies of up to 6 months in duration”
“Tezepelumab was administered to cynomolgus monkeys at doses up to 300 mg/kg SC Q7D for 1, 3, and 6 months; up to 300 mg/kg IV Q7D for 1 month; and at 50 mg/kg IV Q7D for 6 months.”