Tepezza: how long were the pivotal tox studies?

“Adult monkeys have been dosed for up to 39 weeks. Juvenile monkeys were tested in two separate studies (both 13 weeks).”

“Teprotumumab was administered at doses up to 75 mg/kg, with a frequency of 2x/wk in the initial 7-wk study, and 1x/wk in the longer 13-wk and 39-wk studies.”

“GLP toxicology studies in cynomolgus monkeys administered teprotumumab once weekly by intravenous (IV) bolus or slow IV bolus injection.”