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FDA Approves NOVO NORDISK's NovoSeven(R) RT (Coagulation Factor VIIa [Recombinant] Room Temperature Stable) for Hemophilia Patients With Inhibitors
Date:5/13/2008

First Recombinant Room Temperature Stable Treatment for Hemophilia With

Inhibitors Offers More Flexibility and Convenience to Patients

PRINCETON, N.J., May 13 /PRNewswire-FirstCall/ -- Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved NovoSeven(R) 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(R) RT is a new formulation of NovoSeven(R) (Coagulation Factor VIIa [Recombinant]) designed to provide patients with added flexibility when treating their condition.

Hemophilia is a chronic, inherited bleeding disorder that primarily affects males. It is a sex-linked condition, meaning that it is passed on from mother to child on the X chromosome. Approximately 18,000 people in the United States have hemophilia. Thirty percent of these people can develop a complication known as inhibitors. The development of inhibitors is a complication whereby antibodies to conventional factor replacement treatment develop, making treatment more difficult.

"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(R) RT provides the same safety and efficacy as the original NovoSeven(R)-but it can be transported and administered quickly."

NovoSeven(R) 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
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