Novo Nordisk has been given the green light by regulators in the USA for its haemophilia A drug Novoeight.
The US Food and Drug Administration has approved the Danish drugmaker's Biologics License Application for Novoeight (turoctocog alfa), a third-generation recombinant coagulation factor VIII. It has got the thumbs-up for the prevention and treatment of bleeding in people with haemophilia A. Novo currently markets NovoSeven (recombinant factor VIIa) for haemophilia A and B.
The approval is based on what Novo says is "one of the largest and most comprehensive pre-registration clinical trial programmes in the field of haemophilia therapy". The study involved some 210 severe haemophilia A patients and Novoeight demonstrated good efficacy in preventing and treating bleeds and had no confirmed inhibitor development.
Novoeight will be launched in the USA shortly after April 2015, when a third-party patent expires. It will come in a new prefilled device, called MixPro.
Novoeight received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in September 2013, while applications have also been submitted in a range of other countries. Globally it is estimated that 350,000 people have haemophilia A.