In a Phase 3 Trial, NovoEight® Provided Long-term Efficacy and Safety in the Prophylaxis and Treatment of Bleeds in People with Haemophilia A
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Today, at the International Society on Thrombosis and Haemostasis (ISTH) 2015 Congress, Novo Nordisk announced the latest interim data from the guardian(TM)2 extension trial, which showed that in a phase 3 trial, NovoEight(R) (turoctocog alfa) provided long-term efficacy and safety in the prophylaxis and treatment of bleeds in people with severe haemophilia A.
The pivotal guardian(TM) clinical programme was one of the largest and most comprehensive preregistration clinical trial programmes in haemophilia A, with more than 210 patients with severe haemophilia A treated. Interim data collected through 31 December 2013 from 451.6 patient-years on NovoEight(R) show results consistent with previous reports:
- The overall estimated median annual bleeding rate (ABR) achieved during the preventive regimen with NovoEight(R) was 1.56. - During the preventive regimen, 90% of all bleeding episodes were successfully treated with one or two infusions of NovoEight(R).
"These interim results provide an extension to the body of evidence supporting the long-term use of NovoEight(R)," said Dr Margareth Ozelo, IHTC Hemocentro Unicamp, University of Campinas, Campinas, Sao Paulo, Brazil, and guardian(TM)2 investigator. "For people with haemophilia A, finding treatments that are effective at preventing bleeding episodes long-term is essential."
Guardian(TM)2 is a large, multinational extension trial of NovoEight(R) in previously treated patients with haemophilia A from 19 countries who had been enrolled in the pivotal guardian(TM)1 and guardian(TM)3 trials. Patients received NovoEight(R) in a prophylactic regimen and to treat breakthrough bleeds.
These findings now comprise more than four years of data and more than 450 patient years. No inhibitors to factor VIII were detected and no safety issues were identified, supporting the findings from guardian(TM)1 and 3, demonstrating no confirmed inhibitor development in 213 previously treated patients. The most common adverse reactions (greater than or equal to0.5%) seen in the study were injection-site reactions, increased hepatic enzymes and fever.
NovoEight(R) is a B-domain truncated recombinant human coagulation factor VIII for the treatment and prevention of bleeding in patients with haemophilia A. NovoEight(R) has been launched in 11 countries including the US (April 2015) and Japan (May 2014).
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 joints, muscles 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.
Globally, it is estimated that 142,000 people have been diagnosed with haemophilia A.The disease is severely underdiagnosed in developing countries.
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders, and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 39,000 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.com [http://novonordisk.com], Facebook [http://www.facebook.com/novonordisk], Twitter [http://www.twitter.com/novonordisk], LinkedIn [http://www.linkedin.com/company/novo-nordisk], or YouTube [http://www.Youtube.com/novonordisk].
1) Lentz S, Kempton CL, Janic D, et al. Interim results from a large multinational extension trial (guardian(TM)2) using turoctocog alfa for prophylaxis and treatment of bleeding in patients with severe haemophilia A. Abstract presented at: International Society on Thrombosis and Haemostasis (ISTH) 2015 Congress; June 20-25, 2015; Toronto, Canada. 2) NovoEight [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2015. 3) Srivastava A, Brewer AK, Mauser-Bunschoten EP, et al; Treatment Guidelines Working Group on Behalf of the World Federation of Hemophilia. Guidelines for the management of hemophilia. Haemophilia. 2013;19(1):e1-e47. 4) World Federation of Hemophilia. Report on the Annual Global Survey 2012. Published by World Federation of Hemophilia: Montreal, Canada; 2013.
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