Ash2014: novoeight ® from Novo Nordisk effectively reduces the annual bleeding rate (ABR) of high baseline a hematopathy

December 9, 2014 / BIOON / -- the 56th Annual Meeting of the American Society of Hematology (ash) was held in San Francisco from December 6 to 9, 2014 Recently, Novo Nordisk released new analysis data of phase III Guardian project of novoeight ® (turotocog alpha, recombinant coagulation factor VIII), a blood disease drug, at the meeting The guardian-tm1 study showed that the group with the highest annual average bleeding rate (ABR) at the time of novoeight initial treatment showed the largest reduction in the number of bleeding during the duration of treatment Post doc analysis of the guardian-tm2 study further found that compared with ABR in the guardian-tm1 study, ABR decreased by 69% and 63% respectively when the adult and adolescent patient groups continued to receive novoeight ® treatment Guardian-tm1 and guardian-tm3 studies have shown that novoeight ® can effectively prevent and reduce bleeding, and no neutralizing antibodies (inhibitors) against novoeight ® have been produced in 213 patients previously treated with novoeight ® The phase III Guardian project is the largest clinical pre registration trial project carried out so far in patients with type a blood disease, involving more than 200 patients with type a blood disease These phase III clinical trials include patients with severe type a blood disease and pediatric patients who have been previously treated The results of the study prove that novoeight ® can effectively prevent and treat bleeding events, while the patients have no inhibition in vivo Preparations Both the low and high baseline ABR population can benefit from novoeight ® prophylactic treatment Novoeight? Novoeight? Is the third generation of recombinant clotting factor VIII of Nord Nordisk It uses the latest gene recombination and protein purification technology to develop the prevention and treatment of haemorrhagic events in patients with hemophilia A a Currently, novoeight ® has been approved by the United States, the European Union, Japan, Australia and Switzerland for the prevention and treatment of bleeding events in patients with type a blood disease Type a hematopathy is a hereditary disease, which is caused by the lack of coagulation factor VIII It is the most common type of hematopathy in clinic, accounting for 80% - 85% of hematopathy Original English: novoeight ®, phase 3 data show reduction in annualized bleeding rate over time in people with haemophilia A San Francisco, US, 7 December 2014 - today, Novo Nordisk announced a new analysis of phase 3 data demonstrating people with haemophilia A who had the highest annualised bleeding rate (ABR) during initial treatment with NovoEight® (turoctocog alfa) showed the largest reduction in bleeding over the duration of treatment Data for the recombinant factor VIII (rFVIII) product NovoEight® were presented at the 56th Annual Meeting of the American Society of Hematology (ASH).1 The post hoc analysis from the guardian(TM)2 trial further found that, when continued on treatment with NovoEight®, adults and adolescents showed reductions of 69% and 63%, respectively, in ABR compared with their ABRs from guardian(TM)1 The guardian(TM)1 trial (along with guardian(TM)3) showed that NovoEight® was efficacious in preventing and reducing bleeds with no confirmed inhibitor development in 213 previously treated patients.2,3 "This post hoc analysis gives an indication that patients with high baseline bleed rate can benefit from prophylaxis with NovoEight®, as well as patients who maintain low ABR," said Margareth Ozelo, M.D., Ph.D., Hemocentre, IHTC, University of Campinas, Sao Paulo, Brazil, and lead investigator The most common adverse reactions (=>0.5%) seen in the study were injection site reactions, increased hepatic enzymes, and fever.4 About NovoEight® NovoEight® is approved by the US Food and Drug Administration (October 2013) and the European Medicines Agency (November 2013) for the treatment and prophylaxis of bleeding in patients with haemophilia A NovoEight® is also approved in Japan (January 2014), Australia (January 2014), and Switzerland (February 2014), and applications for regulatory approvals have been submitted in a range of other countries About guardian(TM) The pivotal guardian(TM) clinical programme is one of the largest and most comprehensive preregistration clinical trial programmes in haemophilia, with more than 210 patients with severe haemophilia A treated The guardian(TM)2 trial is an extension of the clinical programme The post hoc analysis of the guardian(TM)2 trial involved 166 patients who had participated in guardian(TM)2 and either guardian(TM)1 or 3, had 3 months of exposure to turoctocog alfa prophylaxis during a selected time period (1 January 2012-30 June 2013) in guardian(TM)2 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 into muscles, joints or organs 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.5 Globally, it is estimated that more than 400, 000 people have haemophilia.6 The disease is severely underdiagnosed in developing countries.