Onpattro: how long were the pivotal tox studies?

“Intravenous administration of patisiran-LC (0, 0.3, 1, or 2 mg/kg) to adult monkeys every three weeks for 39 weeks produced no adverse effects on male reproductive organs or on sperm morphology or count.”

“It is noted that no single cell necrosis or adverse findings are found in the 26-week rat study.”

“IV infusion was used in the repeat-dose toxicology studies with in general a once every two- or three-week dosing interval to support the clinical route and timing of dose administration.”