Benlysta: which tox species, and why?

“The non-clinical toxicology program supporting belimumab development has been performed exclusively in the cynomolgus monkey (Macaca fascicularis) based on the following reasons:”

“The cynomolgus monkey was considered as the most relevant species in nonclinical studies since the monkey and human BLyS share 96.4% amino acid identity across the full length protein and 98% amino acid identity in the cleaved soluble portion of BLyS”

“The non-clinical toxicology program supporting belimumab development has been performed exclusively in the cynomolgus monkey (Macaca fascicularis) based on the following reasons:”

“The toxicology of repeat IV administration of belimumab was assessed in two GLP toxicology studies in cynomolgus monkeys of 4 weeks and 6 months duration, respectively.”

“In a reproductive toxicity study in cynomolgus monkeys combining maternal, fetal and neonatal toxicity evaluations, belimumab was administered intravenously to a total of 45 pregnant female monkeys at a dose of either 5 mg/kg (25 animals) or 150 mg/kg (20 animals); twenty-one control animals received vehicle formulation only.”

“Long-term animal studies have not been performed to evaluate the carcinogenic potential of belimumab.”

“The non-clinical toxicology program supporting belimumab development has been performed exclusively in the cynomolgus monkey (Macaca fascicularis) based on the following reasons:”