Leqvio: genotox, carcinogenicity and repro: done or skipped?

“Inclisiran was negative in an adequate panel of mutagenicity assays.”

“Inclisiran lacked tumorigenic potential in these studies.”

“Embryo-fetal assessments in rats and rabbits and a pre and postnatal development study in rats did not demonstrate evidence of reproductive or developmental risk at any dose tested, representing up to 5 and 10 times clinical MRHD (BSA), respectively (≤ 150mg/kg/day in both species).”

“A dedicated safety pharmacology study to evaluate neurological function was not performed; however, neurological evaluations were incorporated into the 40- week repeat dose toxicology study where monkeys were administered 0, 30, 100 or 300 mg/kg inclisiran by subcutaneous injection every 28 days.”