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FDA Approves Novo Nordisk, Inc. (NVO)'s NovoSeven(R) RT (Coagulation Factor VIIa [Recombinant] Room Temperature Stable) for Hemophilia Patients With Inhibitors


5/13/2008 7:46:48 AM

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® 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.

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® RT provides the same safety and efficacy as the original NovoSeven®-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.

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 complex concentrates (aPCCs), to resolve bleeds. Patients with lower responding inhibitors may be treated with high doses of either Factor VIII or Factor IX to stop bleeding.

About NovoSeven® RT and NovoSeven®

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.

For prescribing information, please visit NovoSevenRT.com.

Important Safety Information:

NovoSeven® was studied in 298 patients with hemophilia A or B with inhibitors treated for 1939 bleeding episodes. The most common side effects in people taking NovoSeven® were fever, bleeding, a decrease in the amount of coagulation factor 1, pain from blood collecting in a joint, and high blood pressure. People who have ever had a bad reaction to proteins from mice, hamsters, or "bovines" (such as an ox or cow) should not be treated with NovoSeven®. After taking NovoSeven®, some patients have more of a risk of thrombosis, which is when a clot forms in a blood vessel and causes harm. Although the extent of this risk is not known, it is thought to be small. Some patients have conditions that may increase this risk. These include clogged arteries, blood clots that form throughout the body instead of at the place of injury, a type of blood poisoning called septicemia, and crush injury, which is when a body part is crushed or squeezed between heavy or immobile objects. Also, people taking aPCCs/PCCs (activated or nonactivated prothrombin complex concentrates) at the same time that they're taking NovoSeven® may be at increased risk for thrombosis. Serious adverse events which may or may not have been related to the use of NovoSeven® occurred in 14 of the 298 patients in the initial clinical program. There have been no reports of NovoSeven® causing bad reactions to "analgesics" (such as pain killers), "antibiotics" (the drugs used to treat infection), or "sedatives" (sleeping pills or tranquilizers). Development of antibodies against Factor VII has been reported in Factor VII-deficient patients after treatment with NovoSeven®. These patients had previously been treated with human plasma and/or plasma-derived Factor VII.

About Novo Nordisk

Novo Nordisk is a health care company and a world leader in diabetes care. The company has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. In addition, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy, and hormone replacement therapy.

Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession, and society. With headquarters in Denmark, Novo Nordisk employs more than 23,600 employees in 79 countries and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO'. For more information, visit novonordisk.com.

Media

Sean Clements Novo Nordisk PH: (609) 514-8316

Source: Novo Nordisk


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