Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) adopted a positive opinion on its recombinant factor VIII product turoctocog alfa, with the intended brand name NovoEight®. The Committee recommended marketing authorisation for NovoEight® for the treatment and prophylaxis of bleeding in patients with haemophilia A.
NovoEight® is a recombinant coagulation factor VIII, and based on advanced protein and purification technology, NovoEight® has been designed for reliability, safety and portability for people with haemophilia A.
"We are very excited to be able to offer people with haemophilia in Europe an alternative recombinant FVIII treatment. The positive opinion for NovoEight® is a significant step forward for us in our continued commitment to haemophilia," says Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk.
Novo Nordisk expects to receive the final marketing authorisation from the European Commission within the coming months. Following the Commission's approval, Novo Nordisk expects to launch NovoEight® in Europe early 2014.
NovoEight® has also been filed for marketing authorisation in the US, Japan, Australia and Switzerland.
About NovoEight® and the guardianT programme
NovoEight® was studied in the guardianT 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 treated. In the phase 3 trials guardianT1 and guardianT3, which included previously treated adults and children with severe haemophilia A, NovoEight® demonstrated good efficacy in preventing and treating bleeds, no inhibitor development and all patients in the surgery trial were efficiently treated.
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, which is accomplished by 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.
About Novo Nordisk
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.