“In the pivotal 3- and 6-month toxicity study with 15-week recovery period, SC doses of 0, 25, and 150 mg/kg were administered 2x per week (4/sex/group).”
✓ VerifiedFDA pharmacology/toxicology review, p. 33Source ↗
Pivotal GLP studies
Monkey: 1-month IV with 4-month recovery; combined 3- and 6-month study; enhanced pre- and postnatal development study
“the pivotal (1- mo/acute IV + 4-month recovery; combined 3- and 6-month; enhanced pre- and postnatal development [ePPND]) studies were adequate by design and conduct”
✓ VerifiedFDA pharmacology/toxicology review, p. 5Source ↗
Route in tox
Subcutaneous and intravenous
“SC doses of 0, 25, 75, 100, and 225 mg/kg were administered 2x per week or a single IV dose of 0 or 100 mg/kg was administered”
✓ VerifiedFDA pharmacology/toxicology review, p. 33Source ↗