Ultomiris: how long were the pivotal tox studies?

“The No Observed Adverse Effect Level (NOAEL) for BB5.1 mAb administered to CD‐1 mice via IV injection twice weekly for 26 weeks was determined to be 60 mg/kg/week, the highest dose tested.”

“In the 26‐week repeat‐dose study, mice were administered once or twice weekly by intravenous (IV) injection resulting in doses of 30 or 60 mg/kg/week.”

“In the 26‐week repeat‐dose study, mice were administered once or twice weekly by intravenous (IV) injection resulting in doses of 30 or 60 mg/kg/week.”