Cablivi: how long were the pivotal tox studies?

“In the pivotal 26-week repeat-dose toxicity study in Cynomolgus monkey Cmax- and AUC-levels were 1.5-1.7 times higher in males.”

“Repeat-dose toxicity studies were conducted with caplacizumab in guinea-pigs and Cynomolgus monkeys by i.v. or s.c. routes and designed to achieve continuous maximal target occupancy (target saturation)”

“Toxicokinetic investigations were performed in the repeat-dose toxicity studies in guinea pig and Cynomolgus monkey after both intravenous (i.v.) and subcutaneous (s.c.) administration.”