FDA Approves 8 mg Vial of Novo Nordisk A/S's NovoSeven(R) RT for the Treatment of Hemophilia A or B with Inhibitors and Enhanced Shelf Life for All Vial Sizes

PRINCETON, N.J., Aug. 10 /PRNewswire-FirstCall/ -- Novo Nordisk announced today that the U.S. Food and Drug Administration (FDA) has approved NovoSeven® RT (Coagulation Factor VIIa [Recombinant] Room Temperature Stable) in an 8 mg vial size, making the hemophilia A or B with inhibitors treatment available in 1, 2, 5 and 8 mg vials. The 8 mg vial allows a rapid initiation and administration of this medication for those patients who need a larger dose. In addition, FDA has also approved the extension of shelf life for all vial sizes from 24 months to 36 months at room temperature (at or below 77 degrees Fahrenheit).

NovoSeven® RT is specially formulated to treat people with hemophilia A or B with inhibitors. Hemophilia, which is typically diagnosed in childhood, is a chronic, inherited bleeding disorder that occurs when certain blood clotting factors are missing or do not work properly, resulting in easy bruising and prolonged bleeding from trauma. Spontaneous internal bleeding can occur as well, particularly in the joints and muscles. Inhibitors, a serious complication that can occur after treatment, develop in as many as 30 percent of those with hemophilia. In these cases, antibodies form that neutralize or attack the blood coagulation agents contained in the treatment, resulting in joint disease and making it more difficult to manage bleeds.

"When I get a bleed, I want to infuse my treatment right away. The faster I treat a bleed, the sooner I can continue with my daily routine," said Bob Hoyt, a member of the Novo Nordisk Changing Possibilities Coalition. "Using fewer vials will be a positive change for patients." Hoyt has been living with hemophilia with inhibitors most of his life.

For many people living with hemophilia with inhibitors, the 8 mg vial will allow for faster reconstitution the time it takes to prepare the injection than their current NovoSeven® RT regimen. Those who previously had to use three vials to deliver an 8 mg dose will now have to reconstitute only one vial. Though the amount of powder in the 8 mg vial is larger than the 5 mg vial, the vial will be the same size and will have a yellow cap to distinguish it from the smaller dose.

"We have heard from patients and physicians alike that when they are treating a bleed, every second counts. We at Novo Nordisk are committed to improving the lives of people living with hemophilia with inhibitors," said Eddie Williams, Vice President, Biopharmaceuticals, at Novo Nordisk. "The NovoSeven® RT 8 mg vial will allow patients to get the medicine they need much faster when experiencing a bleed, without having to manage multiple vials. We're also pleased that it will have a positive environmental impact as well fewer vials may mean less waste."

The new vial size is expected to be available by November.

The enhanced stability of all vial sizes will allow for more flexibility when managing treatment supplies another important aspect of hemophilia treatment.

About NovoSeven® RT

Indications and Usage

NovoSeven® RT (Coagulation Factor VIIa [Recombinant] Room Temperature Stable) is 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 Factor VII deficiency and prevention of bleeding in surgical interventions or invasive procedures in patients with congenital FVII deficiency.

Important Safety Information

Warning: Serious thrombotic side effects are associated with the use of NovoSeven® RT outside of uses approved by the FDA. These thrombotic side effects are blood clots that form in arteries and veins and can cause harm and may lead to death. Your doctor should discuss the risks and explain the signs and symptoms of thrombotic side effects to you. Your doctor should monitor you for blood clots during treatment with NovoSeven® RT.

Thrombotic side effects following the use of NovoSeven® RT occurred in 0.28% of all bleeds that were treated for FDA-approved uses. The rate of 0.20% was observed in hemophilia patients with inhibitors, and the rate was higher in patients with acquired hemophilia (4%). Thrombotic events (fatal and non-fatal) have been reported following use of NovoSeven® RT for all FDA-approved uses.

Some patients have conditions that may increase the risk of thrombotic events. These include clogged arteries, blood clots that form throughout the body instead of at the place of injury (called disseminated intravascular coagulation), 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 they are taking NovoSeven® RT may be at increased risk for thrombotic side effects. NovoSeven® RT should be used with caution in patients who have an increased risk for thrombotic side effects. These include, but are not limited to, patients with a history of heart disease, liver disease, patients who have limited movement following surgery, elderly patients, and neonates (babies who are 4 weeks old or younger). In each of these situations, the potential benefit of treatment with NovoSeven® RT should be weighed against the risk of these complications.

Some patients with Factor VII deficiency have developed resistance (antibodies) to Factor VII after treatment with NovoSeven® RT. Factor VII-deficient patients should be monitored for antibody formation before and after administration of NovoSeven® RT.

People who have ever had a bad reaction to NovoSeven® RT or to proteins from mice, hamsters, or "bovines" (such as an ox or cow) should consult their physician prior to using NovoSeven® RT.

The most common side effects during clinical trials in people taking NovoSeven® RT were fever, bleeding, injection site reaction, joint pain, headache, high or low blood pressure, nausea, vomiting, pain, swelling, and rash.

Please visit www.novosevenrt.com for Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

NovoSeven® RT is a prescription medicine.

NovoSeven® is a registered trademark of Novo Nordisk Health Care AG.

About Novo Nordisk

Novo Nordisk is a global healthcare company with more than 87 years of innovation and leadership in diabetes care. The company also has leading positions within hemophilia care, growth hormone therapy and hormone therapy for women. Novo Nordisk's business is driven by the Triple Bottom Line: a commitment to social responsibility to employees and customers, environmental soundness and economic success. Headquartered in Denmark, Novo Nordisk employs more than 29,650 employees in 76 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchange in Copenhagen and its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk-us.com.

SOURCE Novo Nordisk