Fabhalta: which tox species, and why?

“The safety of iptacopan was evaluated in a comprehensive nonclinical program consisting of good laboratory practice compliant toxicology studies in rats and dogs (most sensitive species), a short study in monkeys, reproductive toxicology studies in rats and rabbits, and carcinogenicity assessments in rats and transgenic mice.”

“The safety of iptacopan was evaluated in a comprehensive nonclinical program consisting of good laboratory practice compliant toxicology studies in rats and dogs (most sensitive species), a short study in monkeys, reproductive toxicology studies in rats and rabbits, and carcinogenicity assessments in rats and transgenic mice.”

“Iptacopan administered at the high-dose (~10 times the clinical exposure at the maximum recommended human dose [MRHD], based on plasma area under the concentration-time curve [AUC]) resulted in decreased leukocyte parameters in male dogs at the end of the recovery period.”