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Summary   Background  Recombinant factor  VII a (r FVII a) is approved for use in controlling bleeding episodes in people with hemophilia who have developed inhibitors to replacement therapy. Due to its short half‐life ( t  ½ ), frequent injections are required, limiting its use as a prophylactic treatment. A novel, recombinant fusion protein linking coagulation factor  VII a with albumin (r VII a‐ FP ) has been developed to extend the  t  ½  of r FVII a.    Objectives  The aim of our studies was to investigate the pharmacokinetic/pharmacodynamic characteristics of r VII a‐ FP  in preclinical animal species.    Methods  Pharmacokinetic ( PK ) parameters were derived after single intravenous dosing in hemophilia  A  mice, rats, rabbits and monkeys.  PK  analysis was based on human  FVII  plasma levels determined by measuring  FVII  antigen levels by  ELISA  in mice and rats, and  FVII a activity using  STACLOT  ®   VII a‐r TF  in rabbits and monkeys. Induction of thrombin generation was investigated in mice, while hemostatic activity was assessed by thrombus formation in rabbits.    Results  Compared with r FVII a, r VII a‐ FP  displayed a prolonged  t  ½ , enhanced  in vivo  recovery and reduced clearance in all species investigated. In mice, 16 h after treatment with r VII a‐ FP , thrombin levels were quantifiable, indicating prolonged efficacy, whereas values had approached baseline at this time after treatment with r FVII a. After 12 h, hemostatic efficacy was negligible in r FVII a‐treated rabbits, but sustained in animals receiving r VII a‐ FP .    Conclusions  These studies indicate that the longer  t  ½  of r VII a‐ FP  compared with r FVII a translates into extended activity. These findings suggest that r VII a‐ FP  has the potential to be administered less frequently than r FVII a‐containing concentrates in clinical use.

Pharmacological characteristics of a novel, recombinant fusion protein linking coagulation factor VII a with albumin (rVIIa‐FP)