Recombinant factor VIIa (
NovoSeven) [also known as recombinant
activated factor VII or
eptacog alfa] is a
vitamin K-dependent
glycoprotein that is structurally similar to human plasma-derived
factor VIIa. It is a recombinant product, manufactured using
DNA biotechnology. Intravenous
recombinant factor VIIa has been evaluated in the treatment of
bleeding episodes and for providing haemostasis cover during surgery in patients with certain
bleeding disorders. Large, well controlled trials of
recombinant factor VIIa have not been performed because of the rarity of these
bleeding disorders. However, the efficacy of
recombinant factor VIIa has been investigated in these patients in double-blind dose-finding or noncomparative clinical trials and worldwide compassionate-use programmes.
Recombinant factor VIIa is effective and generally well tolerated in patients with
haemophilia A or B with inhibitors, those with acquired
haemophilia or Glanzmann's
thrombasthenia. Also,
recombinant factor VIIa is a treatment of choice in patients with
haemophilia B with high-responding inhibitors and those with
factor VII deficiency. Direct head-to-head comparisons and robust pharmacoeconomic data are required to fully determine the position of
recombinant factor VIIa in relation to other
therapies. Importantly though, the product appears to be relatively free of antigenicity, thrombogenicity and risk of viral transmission that, in the past, have limited the utility of blood products. Given that these characteristics are important determinants of the place of a treatment in
bleeding disorders,
recombinant factor VIIa provides a valuable treatment alternative in patients with
haemophilia with inhibitors, platelet-refractory Glanzmann's
thrombasthenia or congenital
factor VII deficiency.