Kynamro: how long were the pivotal tox studies?

“Repeat-dose toxicity studies with mipomersen were performed using a subcutaneous injection for time intervals of 3 and 6 months in mice, 13 weeks and 5 months in rats, and 5 weeks, 13 weeks, and 12 months in cynomolgus monkeys.”

“Repeat-dose toxicity studies with mipomersen were performed using a subcutaneous injection for time intervals of 3 and 6 months in mice, 13 weeks and 5 months in rats, and 5 weeks, 13 weeks, and 12 months in cynomolgus monkeys.”

“A 13-Week Toxicity Study and Pharmacokinetic Study of ISIS 301012 Administered by Intravenous Infusion or Subcutaneous Injection to Cynomolgus Monkeys, with a 13-Week Recovery Period”