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Decreased Bleeding Frequency With Secondary Prophylactic Use Of NovoSeven (REG) Shown

Main Category: Blood / Hematology

Article Date: 13 Dec 2006

Data presented at the 48th Annual Meeting of the American Society of Hematology (ASH) from a study testing the use of NovoSeven® Coagulation Factor VIIa (Recombinant) for secondary prophylaxis in patients with hemophilia complicated by inhibitors. The study showed that once-daily NovoSeven®, when used as secondary prophylaxis for a three-month period in patients with hemophilia A or B complicated by inhibitors, significantly reduced the frequency of bleeding episodes, particularly spontaneous joint bleeds, compared with acute treatment only when a bleed occurred. Secondary prophylaxis is when a treatment is used for a defined period of time in anticipation of reducing repeated bleeding, unlike primary prophylaxis, which is when a treatment is used to reduce or prevent joint disease.

"Prophylactic use of clotting factors in hemophilia patients without inhibitors is a widely accepted treatment. For hemophilia patients with inhibitors, treatment is still usually confined to on-demand therapy to treat bleeds," said Ulla Hedner MD, of the University of Lund, Sweden, and vice president of Research & Development of Novo Nordisk A/S, Denmark. "These results are encouraging and indicate there may be potential benefits offered by prophylactic treatment with NovoSeven® to hemophilia patients with inhibitors."

Study and Findings

Bleed frequency was reduced by 45% and 59% with a daily dose of NovoSeven® at either 90ug/kg or 270ug/kg respectively (p<0.0001 for both), compared with the pre-treatment three-month observation period during which therapy was only used at the time of a bleed.[i] In addition, clinically relevant reductions in bleeding were also maintained during the three-month observation period immediately following the three-month treatment period during which only on-demand therapy was used. Bleed frequency was reduced by 27% at 90ug/kg (p<0.0001) and by 50% at 270ug/kg (p<0.0001).1

Data were obtained from a prospective, randomized, double-blind, uncontrolled trial, which studied 22 patients who experience at least four bleeds per month. These results are from the first-ever prospective trial designed to investigate the potential benefits of secondary prophylaxis with a bypassing agent in patients with hemophilia A or B complicated by inhibitors.

Hemophilia patients who have inhibitors (or neutralizing antibodies) against clotting-replacement factor VIII or factor IX experience severe morbidity due to their frequent joint, muscle and deep tissue bleeds and subsequently impaired joint function. They also have frequent pain, disability, regular hospitalizations and considerable absence from school or work.

"Some hemophilia patients with inhibitors, like hemophilia patients without inhibitors, experience frequent bleeds," continued Hedner. "In this study daily use of NovoSeven® for a period of three months offered improvements in bleed frequency."

Secondary prophylaxis with NovoSeven® was not associated with any unexpected safety concerns, and no thromboembolic events were reported during the study.

About Hemophilia

Congenital hemophilia is an inherited bleeding disorder, which primarily affects males, in which the blood does not clot normally due to insufficient clotting factors. It is sex-linked, meaning that it is passed on from mother to child on the X chromosome. About 18,000 people in the United States have hemophilia.

People with congenital hemophilia are lacking blood proteins essential for proper blood clotting and 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 lack Factor IX.

Hemophilia can range from mild, moderate or severe, depending on how much factor protein the body is lacking. In severe cases of hemophilia, factor deficiency can lead to internal bleeding episodes - especially in the joints (knees, ankles and elbows) or bleeding following an injury or surgery. This happens spontaneously and can cause injury to body organs and tissues, and even death. 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

As many as 30 percent of people who have hemophilia can develop a complication known as 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.

About NovoSeven®

NovoSeven® is an activated recombinant version of Factor VII which is functionally indistinguishable from naturally occurring activated Factor VII. NovoSeven® is indicated for the treatment of bleeding episodes and the prevention of bleeding in surgical interventions or invasive procedures in hemophilia A or B patients with inhibitors to the Factor VIII or Factor IX blood clotting proteins and in patients with acquired hemophilia. Additionally, NovoSeven is indicated for the treatment of bleeding episodes in people with congenital Factor VII deficiency; as well as the prevention of bleeding in surgical interventions or invasive procedures in patients with congenital Factor VII deficiency.(3)

NovoSeven® is produced in baby hamster kidney cells which have been genetically engineered to express recombinant Factor VII. The recombinant cell culture system used in the manufacturing of NovoSeven does not involve the use of human plasma or blood products. For prescribing information, please visit http://www.us.novoseven.com/.

Most common adverse events: pyrexia, hemorrhage, injection site reaction, arthralgia, headache, hypertension, hypotension, nausea, vomiting, pain, edema and rash. Patients with disseminated intravascular coagulation (DIC), advanced atherosclerotic disease, crush injury, septicemia, or concomitant treatment with activated or nonactivated prothrombin complex concentrates (aPCCs/PCCs) may have a potential risk of developing thrombotic events in association with NovoSeven treatment. Contraindicated in patients with known hypersensitivity to NovoSeven or mouse, hamster, or bovine protein. The risk of potential interaction between NovoSeven and coagulation factor concentrates has not been evaluated. Simultaneous use of aPCCs/PCCs, should be avoided. Serious adverse events which may or may not have been related to the use of NovoSeven® in acquired hemophilia (10 of 139 patients in the Compassionate Use Program, HTRS registry, and the published literature) may include thrombotic serious adverse events. Serious adverse events which may or may not have been related to the use of NovoSeven occurred in 14 of 298 patients with hemophilia A or B with inhibitors in the initial clinical program.

About Novo Nordisk

Novo Nordisk is a healthcare 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 22,750 employees in 79 countries, and markets its products in 179 countries. For more information, please visit http://www.novonordisk-us.com.

REFERENCES

[1] Konkle BA, et al. Randomized, prospective clinical trial of rFVIIa for secondary prophylaxis in hemophilia patients with inhibitors. Data presented during the 48th Annual Meeting and Exposition of the American Society of Hematology (ASH), Orlando, Florida, USA, 9-12 December 2006 (abstract no. 1028).

[2] Konkle BA, et al. Secondary prophylaxis with rFVIIa improves quality of life of hemophilia patients with inhibitors and frequent bleeds. Abstract presented during the 48th Annual Meeting and Exposition of the American Society of Hematology (ASH), Orlando, Florida, USA, 9-12 December 2006 (abstract no. 766).

[3] NovoSeven. Safety of NovoSeven Coagulation Factor VIIa (Recombinant) http://www.us.novoseven.com/patient/recomSafety_N7Safety.aspx. Accessed September 25, 2006.

For further information please visit:
Novo Nordisk
NovoSeven
American Society of Hematology

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