Search:
 
This image is of a spacer graphic
NHF Face Book NHF Twitter
+ Login to my NHF
+ NHF Membership
+ Donate to NHF
+ Chapter Center
+ Hechos y Respuestas Rápidas
+ Ethics Advisory Committee
This image is of a spacer graphic
-News
 NHF In The News
 NHF eNotes
 Medical Advisories
 Advocacy and Legislative Updates
 Medical News
 Blood Safety News
 NHF and Community News
-Industry News
 Travel Advisory

 

 

 
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