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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

require refrigeration and can be moved in and out of the refrigerator. In addition, NovoSeven(R) 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(R).

NovoSeven(R) 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(R) 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.

About Hemophilia

Patients with hemophilia lack blood proteins essential for proper blood clotting. These patients fall into two categories depending on which blood protein, or factor, they are missing-people with hemophilia A (classic hemophilia) lack Factor VIII, while people with hemophilia B (also known as Christmas disease) lack Factor IX.

Hemophilia can range from mild to moderate or severe, depending on how much factor protein the body is lacking. In severe cases of hemophilia, factor deficiency can lead to spontaneous internal bleeding episodes or bleeding following an injury or surgery. To stop bleeding episodes and manage their disease, people with severe hemophilia infuse themselves with clotting factor therapy-Factor VIII or Factor IX-to replace their missing factor.

Inhibitors

Inhibitors are antibodies that develop and circulate in the bloodstream and neutralize clotting replacement Factor VIII or IX, causing bleeding to continue. Most inhibitors develop in the first nine to 50 days of factor- replacement therapy and are often diagnosed in young children. In rare cases, inhibitors can occur after years of treatment.

Treatment depends on the type of inhibitor. Patients with strong or high-responding inhibitors may be given bypassing agents, such as recombinant Factor VIIa or activated prothrombin comp
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