Bagsværd, Denmark, 16 October 2013 – Today, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has approved its Biologics License Application (BLA) for recombinant coagulation factor VIII, Novoeight®.
The FDA approved Novoeight® for use in adults and children with haemophilia A for:
- Control and prevention of bleeding
- Perioperative management
- Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
Novoeight® has been studied in the guardian™ clinical programme; one of the largest and most comprehensive pre-registration clinical trial programmes in the field of haemophilia therapy with more than 210 severe haemophilia A patients. In the completed trials Novoeight® demonstrated good efficacy in preventing and treating bleeds and had no confirmed inhibitor development, and all patients in the surgery trial were treated effectively. Novoeight® will be launched with the newly introduced prefilled device, MixPro®.
"The approval of Novoeight® marks an important step in offering a new alternative for people with haemophilia A, and demonstrates our commitment to haemophilia," says Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk.
Awaiting the expiration of existing patents, Novo Nordisk plans to launch in the U.S. Novoeight® shortly after April 2015.
Novoeight® received positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in September 2013. Applications for regulatory approval have also been submitted in a range of other countries.
About haemophilia A
Haemophilia is a chronic, inherited bleeding disorder that primarily affects males. People with haemophilia A are either missing or have a malfunctioning factor VIII protein, which is essential for proper blood clotting. People with haemophilia A have a tendency to bleed longer than most, or to bleed internally, because they are missing this clotting factor. To manage the disease and stop bleeding, people with haemophilia A must replace the missing factor VIII protein through intravenous injection of the clotting factor.
Globally it is estimated that 350,000 people have haemophilia A. The disease is severely under-diagnosed in developing countries.
Headquartered in Denmark, Novo Nordisk is a global healthcare company with 90 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy. Novo Nordisk employs approximately 36,000 employees in 75 countries, and markets its products in more than 180 countries. For more information, visit novonordisk.com.