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FDA Approves Novo Nordisk's NovoEight

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The share price of Novo Nordisk (NVO) continued to increase following approval from the U.S. Food and Drug Administration (:FDA) for its hemophilia A candidate, NovoEight.

NovoEight is approved in the U.S. for treating adults and children with hemophilia A for control and prevention of bleeding, perioperative management and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

Novo Nordisk sought approval for NovoEight from the FDA based on results from the guardian program. The program enrolled more than 210 patients suffering from hemophilia A. Novo Nordisk stated in its press release that roughly 350,000 patients across the world have hemophilia A.

Novo Nordisk is likely to launch NovoEight in the U.S. after Apr 2015, that is, after the expiration of existing patents. The company did not provide details regarding the same.

The European approval of NovoEight in the hemophilia A indication is on track with the European Medicines Agency’s (:EMA) Committee for Medicinal Products for Human Use (CHMP) rendering a favorable opinion on the issue. It has also filed for approval in Japan, Australia and Switzerland.

We are encouraged by Novo Nordisk’s progress in developing treatments for hemophilia. Novo Nordisk also has N8-GP in its pipeline. N8-GP, a hemophilia A candidate, whose phase III study is scheduled to finish in the first half of 2014.

Another candidate, N9-GP, for the treatment of hemophilia B is in phase III development. The company expects to file N9-GP for approval in 2015, after the completion of the two phase III studies in the paradigm program.

Currently, the hemophilia market has drugs like Advate, Xyntha, Recombinate and Kogenate FS. Biogen Idec Inc. (BIIB) is currently looking to get its hemophilia A candidate, Eloctate, approved in the U.S. Biogen expects approval for Eloctate in the second quarter of 2014.

Novo Nordisk currently carries a Zacks Rank #3 (Hold). Currently, companies like Roche (RHHBY) and AMAG Pharmaceuticals Inc. (AMAG) look attractive with a Zacks Rank #1 (Strong Buy).

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