European Commission approves NovoSeven® in two new indications (19 Feb 2004)
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Novo Nordisk A/S has announced that the European Commission has approved NovoSeven® (Eptacog alfa (activated)) for the control of bleeding in patients with factor VII deficiency and Glanzmann’s thrombasthenia refractory to platelet transfusions.
Factor VII deficiency and Glanzmann’s thrombasthenia are rare, inherited coagulation disorders which can result in uncontrollable, life-threatening bleedings. As the first genetically engineered or recombinant product that has been licensed for use in these disorders, NovoSeven® does not have any added human plasma proteins in the manufacturing process. Thereby the risk of human viral transmission is eliminated.
Factor VII deficiency has so far been treated with products containing factor VII made from human plasma, or with NovoSeven®, as off-label use, while transfusions of platelets have been used to treat patients with Glanzmann’s thrombasthenia. Repeated platelet transfusions can result in the development of platelet antibodies, making subsequent platelet transfusions ineffective. This is a very serious complication for patients with Glanzmann’s thrombasthenia because they become refractory to treatment.
A number of studies and case reports have concluded that NovoSeven® is an effective agent for the treatment of spontaneous bleeding and for the control of bleeding during surgery in patients with factor VII deficiency or Glanzmann’s thrombasthenia refractory to platelet transfusions. NovoSeven® was shown 92% effective in factor VII deficiency patients and 96% effective in Glanzmann’s thrombasthenia patients for stopping bleeding episodes., No bleeding occurred neither during nor after any of the 20 surgical procedures evaluated in factor VII deficiency patients, or in any of the surgical procedures evaluated in patients with Glanzmann’s thrombasthenia.,
“Until now there has been no effective treatment for patients with Glanzmann’s thrombasthenia who are refractory to platelets,” says Professor Guglielmo Mariani, from University of L’Aquila, Italy. Now we can treat bleeding in people with factor VII deficiency quickly and effectively, and without the risk of transmission of human blood-borne pathogens.”
A multinational placebo-controlled study in 280 trauma patients with critical bleedings recently confirmed that NovoSeven® reduced the need for transfusion without increasing the risk of thromboembolic events. This study result together with the extension of the above two new indications, confirm Novo Nordisk’s vision of establishing NovoSeven® as the preferred haemostatic agent for critical bleedings, says Mads Krogsgaard Thomsen, chief science officer.
NovoSeven® is an activated recombinant version of factor VII which is functionally indistinguishable from naturally occurring activated factor VII. The product is currently registered for treatment of bleeding episodes in congenital haemophilia patients with inhibitors, and acquired haemophilia patients.
NovoSeven® is produced in baby hamster kidney cells which have been genetically engineered to express recombinant factor VII. Because no human albumin is added as a stabiliser, nor is any other human proteins used during manufacturing or added to the final product, there is no risk of human blood-borne pathogen transmission.
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 haemostasis 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 approximately 18,800 full-time employees in 69 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.
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 In patients with antibodies to GPIIb-IIIa and/or HLA, and with past or present refractoriness to platelets.
 Mariani G, MG Testa, T Di Paolantonio, et al, Use of recombinant, activated factor VII in the treatment of congenital factor VII deficiencies. Vox Sang, 1999;77:131-6.
 Poon MC, O Katsarou and A Huth-Kuehne, Recombinant factor VIIa in congenital platelet bleeding disorders. Blood, 2000;96:256a.