Voydeya: how long were the pivotal tox studies?

“No danicopan-related effects were observed on heart rate, RR, PR, QT, QTc (using Van de Water’s formula) intervals, and QRS complex duration at the approximate time to maximum concentration (Tmax) in a repeat-dose oral toxicity study in beagle dogs dosed up to 150 mg/kg/day (75 mg/kg, BID) for 39 weeks (ACH-15-057, GLP-compliant).”

“Toxicological characterization of danicopan was evaluated in beagle dogs (5 days, 2-weeks, 13- weeks, 13-weeks, and 9 months), wistar han (WH) rats (14 days, 28-days, 13-weeks, and 6- months)”

“The pivotal repeat-dose oral toxicology studies were conducted in accordance with GLP regulations”