WAPPS-Hemo is pleased to announce the launch of two new population pharmacokinetic (PK) models for ESPEROCT® (Antihemophilic Factor VIII (Recombinant, B-Domain Truncated), PEGylated) that use the one-stage and chromogenic assays. The models were built on PK data, gifted from Novo Nordisk, from four clinical trials (two Phase I and two Phase III) encompassing 299 Hemophilia A patients between the ages of 1 and 71 years. The model is a one-compartment model with between subject variability on the clearance and volume terms. Significant covariates include fat-free mass on clearance and volume and age on clearance. There was very good precision of half-life and time to 2% estimates when prior infusion information was available (see figure for one-stage model). Clinicians are now able to select Esperoct® in WAPPS to receive individual PK estimates for their patients and to use the clinical calculator for dose regimen design.
