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Novo’s rFVIII Receives Recommendation for EMA Marketing Approval

Novo Nordisk has received a recommendation for marketing approval from a committee of the  European Medicines Agency (EMA) for its hemophilia treatment turoctocog alfa, a third-generation recombinant factor VIII (rFVIII) product intended for prevention and treatment of bleeding in people with hemophilia A.


During Phase III clinical trials, the new drug, also called NovoEight®, was effective in preventing and treating bleeds in adults and children who had been previously treated. It also was effective in patients undergoing surgery. Further, none of the patients in the trials developed inhibitors.


The company expects to receive final marketing authorization from the European Commission in two to three months. It will launch the drug in Europe in early 2014. Novo Nordisk has also filed for marketing authorization of NovoEight in the US, Japan, Australia and Switzerland.


“We are very happy to now have treatment in this mainstream hemophilia market, which we have never had before,” said Novo Chief Science Officer Mads Krogsgaard Thomsen.


Source: Reuters, September 20, 2013