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Novo Nordisk Seeks Regulatory Approval for Recombinant FVIII Drug

November 1, 2012

Novo Nordisk recently announced the submission of the regulatory application for turoctocog alfa (NN7008) to the European Medicines Agency and the US Food and Drug Administration. Turoctocog alfa is a third-generation recombinant factor VIII product intended for prevention and treatment of bleeding in people with hemophilia A. The applications were submitted after  two successfully completed global clinical trials in 2011.

The phase III trials, known as guardian™1 and guardian™3, enrolled 200 previously treated adults and children with severe hemophilia A. According to the Novo Nordisk press release, the results showed that turoctocog alfa demonstrated “efficacy in preventing and treating bleeds with no development of inhibitors.” The company also plans to submit additional regulatory applications to additional countries.

“We are very excited about having reached this goal. Turoctocog alfa represents a new treatment alternative for people with hemophilia A and is one of the first important outcomes of the hemophilia research strategy we embarked upon in 2006,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.

Novo Discontinues Development of Vatreptacog alfa

In other news, Novo Nordisk said it would discontinue development of another hemophilia therapy, vatreptacog alfa. The decision was made in response to the development of inhibitor antibodies in a handful of clinical trial enrollees.

Source: Novo Nordisk press release dated October 16, 2012, Reuters, September 28, 2012