“Toxicity studies of daclizumab were conducted in monkeys with up to 39 weeks duration.”
✓ VerifiedFDA pharmacology/toxicology review, p. 2Source ↗
Pivotal GLP studies
Cynomolgus 13-week, 39-week and 9-month SC studies, dosed every 2 weeks, with 3-month recovery
“The pivotal studies were 13- and 39-week studies and a 9-month study. All were conducted with DAC HYP, administered Q2W by subcutaneous injection, and included 3-month recovery periods.”
✓ VerifiedFDA pharmacology/toxicology review, p. 5Source ↗
Route in tox
Subcutaneous (clinical route), every 2 weeks
“Repeat-dose toxicology studies were conducted with daclizumab administered SC (clinical and commercial route of administration) q2W.”