The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) adopted a positive opinion on Novo Nordisk's 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.
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.
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.
Headquartered in Denmark, Novo Nordisk is a global healthcare company with 90 years of innovation and leadership in diabetes care.