Ayvakit: how long were the pivotal tox studies?

“choroid plexus edema in the brain occurred in dogs at doses greater than or equal to 7.5 mg/kg/day (approximately 4.7, 1 or 0.4 times the human exposure based on AUC at the 25 mg, 200 mg or 300 mg dose, respectively), but were not observed in a 9-month study at 5 mg/kg/day.”

“Local tolerance was assessed by reviewing the digestive track changes in the GLP-compliant 28-day and 3-month toxicology studies in rats and dogs.”

“3-month oral (gavage) toxicity and toxicokinetic study in Sprague Dawley rats”