Hemlibra: which tox species, and why?

“Emicizumab was shown to bind similarly to the corresponding cynomolgus monkey coagulation factors, as such the cynomolgus monkey is a pharmacologically relevant species.”

“In an enzyme assay using purified Cynomolgus monkey, rat and mouse FIXa and FX, emicizumab was found to cross-react only with the corresponding clotting factors of Cynomolgus monkeys.”

“Emicizumab was generally well tolerated in a 26-week toxicology study conducted in cynomolgus monkeys administered weekly SC doses of emicizumab at 1, 6, and 30 mg/kg.”