FDA Approves Coagulation Drug NovoEight (Turoctocog Alfa)
Launch planned after April 2015 (October 16)
The FDA has approved the Biologics License Application (BLA) for recombinant coagulation factor VIII (NovoEight [turoctocog alpha]).
The FDA approved the drug for use in adults and children with hemophilia A for:
- Control and prevention of bleeding
- Perioperative management
- Routine prophylaxis to prevent or reduce the frequency of bleeding episodes
The pre-registration clinical trial program for NovoEight included more than 210 patients with severe hemophilia A. In the completed trials, the drug demonstrated good efficacy in preventing and treating bleeds and had no confirmed inhibitor development.
Awaiting the expiration of existing patents, the drug’s developer (Novo Nordisk) plans to launch NovoEight in the U.S. shortly after April 2015. The drug will be marketed in a prefilled device, MixPro.
Globally, it is estimated that 350,000 people have hemophilia A.
Source: Novo Nordisk; October 16, 2013.