UK, Danish Launch For Novo's NovoSeven

Novo Nordisk of Denmark has launched its recombinant coagulation Factor VIIa product NovoSeven (eptacog alfa) onto the UK and Danish markets for the treatment of serious bleeding events and surgery in patients who have developed inhibitors to Factors VIII and IX.

The drug was first launched earlier this year in Switzerland, and has also been approved in Norway. In the UK, NovoSeven is priced at L705 ($1,081) per 1.2mg vial. The recommended dose is between 3 and 6mcg/kg per single dose, given as an intravenous bolus injection. Administration is two to five minutes, at dose intervals of two to three hours initially, and then every four to 12 hours.

Target Patients Approximately 3.5%-25% of hemophiliacs develop inhibitory antibodies to Factor VIII. Current treatment of bleeding episodes in resistant patients varies according to the level of inhibition. Patients with low-level inhibition often respond to repeated infusions of Factor VIII within a few days. Mid-range inhibition is usually treated with porcine Factor VIII, which tends to have only partial cross-reactivity with the antibodies. However, with repeated infusions, porcine Factor VIII rapidly stimulates its own antibody response and subsequent infusions lose their effectiveness. In patients with high levels of antibodies, treatment is usually with infusions of prothrombin complex concentrates.