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Novo Nordisk Study Suggests Secondary Prophylaxis Reduces Number of Bleeds

Results from a study sponsored by Novo Nordisk to evaluate the effectiveness of a once-daily, prophylactic treatment regimen using NovoSeven®, the company’s recombinant factor VIIa product, were reported at the American Society of Hematology’s 48th Annual Meeting December 9-12, 2006 in Orlando, FL. The data indicated that when hemophilia patients with inhibitors were treated once a day with NovoSeven® as secondary prophylaxis, they experienced a significantly reduced number of bleeding episodes.

Secondary prophylaxis is a therapeutic regimen of factor infusions for a finite time period. This therapy is used to stop repeated bleeding in the same joint or to prevent an expected bleed.

The presence of an inhibitor often complicates treatment and can result in exorbitant health care costs. An inhibitor is an inhibitory antibody produced by the body in response to infused factor VIII or IX.  The results from this Novo Nordisk trial may lead to new treatment options for patients with inhibitors.

The trial was conducted at 17 sites worldwide. All 22 hemophilia A and B patients enrolled in the study had inhibitors and were given a once-daily dose of NovoSeven® for three-months. Depending on which of two dosing amounts were prescribed, patients showed either a 45% or 59% reduction in bleeding frequency, compared to a pre-study observation period in which the patients were only treated at the onset of a bleed.

“These results are encouraging and indicate there may be potential benefits offered by prophylactic treatment with NovoSeven® to hemophilia patients with inhibitors,” said Ulla Hedner, MD, of Lund University in Sweden, and Vice President of Research & Development of Novo Nordisk A/S in Denmark. In the 1980s Hedner led the research team at Novo Nordisk that discovered the recombinant factor VIIa product, which was named NovoSeven®.

Source: MediLexicon, posted online on December 13, 2006