Enspryng: how long were the pivotal tox studies?

“In general toxicity studies in monkey, weekly subcutaneous doses of up to 50 mg/kg for 4 or 26 weeks resulted in no notable toxicity or effects on male (sperm analysis) and female (menstrual cycle) reproductive parameters and organs.”

“In general toxicity studies in monkey, weekly subcutaneous doses of up to 50 mg/kg for 4 or 26 weeks resulted in no notable toxicity or effects on male (sperm analysis) and female (menstrual cycle) reproductive parameters and organs.”

“In the general toxicity studies, no adverse effects were observed in monkeys administered satralizumab (0, 2, 10, or 50 mg/kg/week SC) for 4 or 26 weeks.”