FDA Approves Novo Nordisk's NovoSeven RT for Hemophilia Patients With Inhibitors

Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved NovoSeven RT (Coagulation Factor VIIa [Recombinant] Room Temperature Stable), the first room temperature stable recombinant product available for the treatment of bleeding episodes in patients with hemophilia with inhibitors. NovoSeven RT is a new formulation of NovoSeven (Coagulation Factor VIIa [Recombinant]) designed to provide patients with added flexibility when treating their condition.

“People with hemophilia, who already make lifestyle compromises because of this disorder, are often encumbered by their treatments. As a result, going places or participating in any activity outside the home becomes more difficult because treatment portability, preparation, and administration have been restrictive,” stated Eddie Williams, Vice President, Biopharmaceuticals, at Novo Nordisk. “Novo Nordisk is constantly looking for ways to help solve the unique challenges these patients face. The new NovoSeven RT provides the same safety and efficacy as the original NovoSeven(R)-but it can be transported and administered quickly.”

NovoSeven RT has been manufactured to be room temperature stable (from 36 degrees F to 77 degrees F outside a refrigerator). The new formulation does not require refrigeration and can be moved in and out of the refrigerator. In addition, NovoSeven RT has a higher concentration for lower infusion volumes and quick administration. The needed infusion amount is almost half of that needed with the original NovoSeven.

NovoSeven RT will be available in August 2008, and a new infusion kit with needle-free adapters will be offered separately. As a recombinant therapy, NovoSeven RT is the only room temperature stable treatment for hemophilia with inhibitors that is not plasma-derived and, therefore, poses no risk of human viral transmission through its use.

NovoSeven RT and NovoSeven are indicated for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to FVIII or FIX and in patients with acquired hemophilia; prevention of bleeding in surgical interventions or invasive procedures in hemophilia A or B patients with inhibitors to FVIII or FIX and in patients with acquired hemophilia; treatment of bleeding episodes in patients with congenital FVII deficiency and prevention of bleeding in surgical interventions or invasive procedures in patients with congenital FVII deficiency.

Release Date: May 13, 2008
Source: Novo Nordisk