Novo Nordisk’s Novoeight Drug Approved by FDA
Novo Nordisk has received approval from US regulatory body, the Food and Drug Administration (FDA) for their haemophilia A drug.
The regulatory board have approved the Novo Nordisk’s Biologics License Application for Novoeight (turoctocog alfa), a third-generation recombinant coagulation factor VIII.
The drug received the green light for the prevention and treatment of bleeding in people with haemophilia A.
The approval is centred on what Novo Nordisk claim was “one of the largest and most comprehensive pre-registration clinical trial programmes in the field of haemophilia therapy”.
The clinical study involved around 210 severe haemophilia A patients and demonstrated that the drug showed good efficacy in preventing and treating bleeds and had no confirmed inhibitor development.
Novoeight will be launched in the US shortly after April 2015, when the patents expire for Novo Nordisk’s currently-marketed haemophilia NovoSeven (recombinant Factor VIIa).
The drug has also received a positive response from the European Medicines Agency’s Committee for Medicinal Products for Human Use in September 2013.