Simponi: how long were the pivotal tox studies?

“In the 6-month subcutaneous study, using doses up to 50 mg/kg, no adverse effects due to golimumab treatment were seen on standard parameters.”

“following single or repeated dosing of cynomolgus monkeys via intravenous or subcutaneous administration at doses up to 50 mg/kg once or twice weekly for up to 6 months.”

“Golimumab was evaluated in subcutaneous and intravenous repeated-dose toxicity studies using doses up to 50 mg/kg either weekly or twice weekly.”