“In the pivotal general toxicology studies of SC vutrisiran in rat (13- and 26-week) and cynomolgus monkey (13- and 40-week), non-adverse findings were observed in the liver (both species), kidneys (rat), and lymph nodes (monkey).”
✓ VerifiedFDA pharmacology/toxicology review, p. 9Source ↗
Pivotal GLP studies
Rat 13-week and 26-week SC monthly; monkey 13-week and 9-month (40-week) SC every 4 weeks
“Frequency of dosing: Every 4 weeks, Day 1 to Day 281 Route of administration: SC injection to the dorsal region”
✓ VerifiedFDA pharmacology/toxicology review, p. 37Source ↗
Route in tox
Subcutaneous, monthly (every 4 weeks)
“Frequency of dosing: Every 4 weeks, Day 1 to Day 281 Route of administration: SC injection to the dorsal region”
✓ VerifiedFDA pharmacology/toxicology review, p. 37Source ↗