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Coagulation Factor Wins U.S. Approval - Novo Nordisk wins FDA approval to market NovoSeven coagulation factor - Company Business and Marketing

Applied Genetics News,  April, 1999  

Novo Nordisk (Novo Alle DK-2880, Bagsvaerd, Denmark; Tel: 212/867- 0123, Fax: 212/867-0298, Website: www.novo.dk) has received Food and Drug Administration (FDA) approval to market NovoSeven coagulation factor VIIa (recombinant) for the treatment of bleeding episodes in patients with hemophilia A or B and who have antibody inhibitors of Factors VIII or IX.

Bleeding episodes in hemophilia patients are usually treated with the administration of blood clotting factors VIII or IX, which are deficient in patients with hemophilia A or B, respectively. Approximately 10% of patients develop antibodies to the administered clotting factors, rendering the treatment ineffective. NovoSeven speeds clotting through a mechanism that induces hemostasis independently of factors VII or IX. NovoSeven binds to "tissue factor", a protein expressed in the damaged vessel wall and the complex activates the coagulation system and hence clot formation at the site of injury. Worldwide, approximately 50,000 hemophilia patients are treated with blood factor products. About 3,500 of these have antibody inhibitors and represent the market for NovoSeven.

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