Rapiblyk: how long were the pivotal tox studies?

“Reports of intravenous bolus and continuous infusion studies in rats and dogs up to 4-week duration were available.”

“In addition to a single dose 24-hr infusion study conducted by AOP Health, a 4-week i.v. bolus study in rats and dogs and a continuous infusion study of the same duration in dogs with ONO-1101 were cited.”

“Most of the toxicity studies conducted with ONO-1101 that the applicant cited were conducted with daily intravenous bolus doses, while intravenous infusion is recommended for the clinical use.”