ORIGINAL ARTICLE Pharmacological characteristics of a novel, recombinant fusion

(rFVIIa) is approved for use in controlling bleeding epi-sodes in people with hemophilia who have developed inhibitors to replacement therapy. Due to its short half-life (t), frequent injections are required, limiting its use as a prophylactic treatment. A novel, recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP) has been developed to extend the t of rFVIIa. Objectives: The aim of our studies was to investi-gate the pharmacokinetic/pharmacodynamic characteris-tics of rVIIa-FP in preclinical animal species. Methods: Pharmacokinetic (PK) parameters were derived after sin-gle intravenous dosing in hemophilia A mice, rats, rabbits and monkeys. PK analysis was based on human FVII plasma levels determined by measuring FVII antigen lev-els by ELISA in mice and rats, and FVIIa activity usin