“In toxicology studies up to 6 months duration, no target organs of toxicity were identified at a SC dose of 10 mg/kg or intravenous (IV) doses of 10-100 mg/kg administered once every 4 weeks for a total of 7 doses.”
✓ VerifiedFDA pharmacology/toxicology review, p. 2Source ↗
Pivotal GLP studies
Cynomolgus monkey 6-month study: 10 mg/kg SC or 10/100 mg/kg IV once every 4 weeks, 7 doses
“In a 6-month toxicology study, Cynomolgus monkeys received mepolizumab (SB240563) at a subcutaneous dose of 10 mg/kg or an intravenous dose of 10 or 100 mg/kg once every 4 weeks for a total of 7 doses”
✓ VerifiedFDA pharmacology/toxicology review, p. 59Source ↗
Route in tox
IV and SC
“In a 6-month toxicology study, Cynomolgus monkeys received mepolizumab (SB240563) at a subcutaneous dose of 10 mg/kg or an intravenous dose of 10 or 100 mg/kg once every 4 weeks for a total of 7 doses”
✓ VerifiedFDA pharmacology/toxicology review, p. 59Source ↗