Wainua: how long were the pivotal tox studies?

“In a 39-week study in cynomolgus monkeys, eplontersen (0, 5, 10, or 25 mg/kg SC Q4W) resulted in an increase in complement Bb in HDM, basophilic granules in liver Kupffer cells and kidney tubular cells at the HD, and granular macrophages in the lymph nodes at all doses.”

“The nonclinical studies of eplontersen submitted to the NDA included general toxicology studies of up to 26 weeks (mouse) and 9 months (monkey) in duration”

“The toxicity of eplontersen was investigated with different s.c. administration regimen (weekly, biweekly, monthly) for up to 26 weeks in mice, 14 weeks in rats and up to 39 weeks in monkeys.”