Welireg: which tox species, and why?

“The safety of belzutifan was evaluated in GLP-compliant repeat-dose toxicology studies up to 3- month duration in rats and dogs using the intended oral route of administration.”

“It can be concluded that especially dogs and to a lesser extent rats exhibit a similar pharmacokinetic profile of belzutifan compared to humans and are therefore appropriate for toxicological assessment of belzutifan.”

“The safety of belzutifan was evaluated in GLP-compliant repeat-dose toxicology studies up to 3- month duration in rats and dogs using the intended oral route of administration.”

“The safety of belzutifan was evaluated in GLP-compliant repeat-dose toxicology studies up to 3- month duration in rats and dogs using the intended oral route of administration.”

“No further rabbit studies were conducted based on the identified risk in the rat embryo-fetal development study”

“The applicant justified in depth why the results of the 2-year carcinogenicity study in rats would not be required for this MAA, and presented the results of the 6-month Tg. rasH2 mouse carcinogenicity study with belzutifan at doses up to 600 mg/kg/day.”

“The safety of belzutifan was evaluated in GLP-compliant repeat-dose toxicology studies up to 3- month duration in rats and dogs using the intended oral route of administration.”