Saphnelo: how long were the pivotal tox studies?

“Repeat-dose toxicity of anifrolumab was evaluated in cynomolgus monkeys in 4-weeks and 39-weeks GLP toxicity studies with an additional recovery period of 7 or 12 weeks, respectively.”

“Repeat-dose toxicity of anifrolumab was evaluated in cynomolgus monkeys in 4-weeks and 39-weeks GLP toxicity studies with an additional recovery period of 7 or 12 weeks, respectively.”

“In this study, cynomolgus monkeys were given 40 IV infusion (30 minutes) doses of anifrolumab at 5 and 50 mg/kg/week once a week (QW) or 40 subcutaneous (SC) injection doses of anifrolumab at 15 and 60 mg/kg/week QW.”