Hemlibra: how long were the pivotal tox studies?

“A 26-week intermittent dose (once weekly, 27 doses) subcutaneous administration toxicity study of CH5534262 in mature cynomolgus monkeysfollowed by a 13-week recovery period / Study report no. 1060134”

“Repeat-dose toxicity was also evaluated in cynomolgus monkeys dosed once weekly in a 4-week IV dose toxicity study (1060140) and 4- and 13-week SC dose toxicity studies (1060133 and 1060134).”

“In the vast majority of the nonclinical studies, emicizumab was administered via the SC route administration as this mimics the proposed clinical route.”