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FDA Approves BLA for Novo Nordisk’s New rFVIII Product

Last month, Novo Nordisk announced approval by the US Food and Drug Administration (FDA) of its Biologics License Application (BLA) for Novoeight®, the company’s recombinant factor VIII therapy.


The approved indications for Novoeight® include use in adults and children with hemophilia A for the control and prevention of bleeding, perioperative management and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.


According to a Novo Nordisk press release, Novoeight® has been evaluated via the guardian™ clinical program, which included more than 210 patients with severe hemophilia A. In the completed trials, Novoeight® demonstrated good efficacy in preventing and treating bleeds. No patients developed inhibitors (antibodies to infused factor protein), and all patients in the surgery trial were treated effectively. Novoeight® will be launched with the newly introduced prefilled device, MixPro®.


“The approval of Novoeight® marks an important step in offering a new alternative for people with hemophilia A, and demonstrates our commitment to hemophilia,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk. The company plans to launch Novoeight® in the US soon after April 2015, upon the expiration of existing patents.


Source: Novo Nordisk press release dated October 25, 2013