“Two six-month toxicity studies were conducted in cynomolgus monkeys, one by IV (twice weekly) and the other by SC (once weekly) routes of administration.”
✓ VerifiedFDA multi-discipline review, p. 66Source ↗
Pivotal GLP studies
GLP monkey 4-week IV/SC study, 6-month weekly SC study and 6-month twice-weekly IV study
“The pivotal studies included a 4-week repeat dose toxicity study which used both subcutaneous and intravenous routes of administration, and two 6-month repeat dose toxicity studies, one using weekly subcutaneous injections and the second using twice weekly intravenous injections.”
“Two six-month toxicity studies were conducted in cynomolgus monkeys, one by IV (twice weekly) and the other by SC (once weekly) routes of administration.”
✓ VerifiedFDA multi-discipline review, p. 66Source ↗