Givlaari: how long were the pivotal tox studies?

“In a 39-week monkey study, cynomolgus monkeys were subcutaneously administered vehicle or givosiran (10, 30, or 100 mg/kg) once weekly for 39 weeks followed by a 13-week recovery period.”

“Dawley rats were subcutaneously administered vehicle or givosiran (3, 10, or 30 mg/kg) once weekly for 26 weeks followed by a 13-week recovery period.”

“The studies were conducted using the subcutaneous route of administration, which is consistent with the intended clinical route of administration; however, animals were dosed once weekly instead of the once monthly dose schedule used to treat patients.”