“The primary nonclinical toxicity studies of alirocumab were conducted in rats and monkeys for up to 6 months duration with weekly subcutaneous and intravenous dosing.”
✓ VerifiedFDA pharmacology/toxicology review, p. 2Source ↗
Pivotal GLP studies
Rat and monkey studies up to 6 months, weekly SC and IV dosing
“The primary nonclinical toxicity studies of alirocumab were conducted in rats and monkeys for up to 6 months duration with weekly subcutaneous and intravenous dosing.”
✓ VerifiedFDA pharmacology/toxicology review, p. 2Source ↗
Route in tox
SC and IV (weekly)
“Route of administration Groups 2-4, subcutaneous: 5, 15, and 75 mg/kg/week Group 5, intravenous infusion (~30 min): 50 mg/kg/week only”
✓ VerifiedFDA pharmacology/toxicology review, p. 62Source ↗