COPENHAGEN, Denmark I May 12, 2014 I Today, Novo Nordisk announced new phase 3 interim data from its guardianT2 trial for its recombinant coagulation factor VIII (rFVIII) product NovoEight® (turoctocog alfa), the first new rFVIII molecule in over a decade, which shows that it provides long-term reduction from bleeding in people with haemophilia A when used as a preventative treatment.1 The results were presented at the World Federation of Haemophilia (WFH) World Congress and support findings from other studies within the guardianT clinical programme that found NovoEight® demonstrated good efficacy in preventing and treating bleeds without inhibitor development in previously treated patients.2,3
Commenting on the results, Dr Margareth Ozelo, Hemocentre, IHTC, University of Campinas, Sao Paulo, Brazil and guardianT2 investigator said, “As a physician treating haemophilia A, having another FVIII product available is good news and can lead to improved treatment outcomes and quality of life for our patients. Reducing the number of bleeding episodes is a key consideration as they are very painful and frightening for patients and caregivers and can lead to severe long-term joint damage or arthropathy.”
NovoEight® has been carefully designed using advanced protein and purification technology to provide a reliable and portable treatment option for people with haemophilia A combined with a good safety profile.4 NovoEight® offers convenient and flexible storage requirements and can be stored at 30?C/86?F for 6 months giving patients the freedom to administer whenever and wherever needed.5,6
Phase 3 guardianT2 results:
GuardianT2 is the extension of the pivotal guardianT clinical programme, one of the largest and most comprehensive pre-registration clinical trial programmes in haemophilia, with more than 210 severe haemophilia A patients treated. GuardianT2 is an open-label, multinational, single-arm extension trial involving 188 haemophilia A patients from 18 countries who had been previously enrolled in the guardianT1 and guardianT3 trials. Patients received NovoEight® in a preventative regimen and to treat breakthrough bleeds. Interim results found:1
. The overall estimated annual bleeding rate (ABR) achieved during preventative regimen with NovoEight® was 1.7 (median 3.1) bleeds/patient/year, ranging from 1.4 (children aged 0-5) to 1.9 for adults (median number of bleeds/patient/year)
. Preventative regimen with NovoEight® led to a decrease in ABR, followed by stabilisation at a lower level over the time period assessed.
About NovoEight®
NovoEight® has been approved by the FDA (October 2013) and EMA (November 2013) for the treatment and prophylaxis of bleeding in patients with haemophilia A. NovoEight® has also been approved in Japan and Australia (January 2014) and in Switzerland (February 2014) and applications for regulatory approvals have been submitted in a range of other countries.
Novo Nordisk in Haemophilia
In addition to NovoEight®, Novo Nordisk has developed a comprehensive portfolio of molecules aimed at improving haemophilia treatment. Marketed products include NovoSeven® for the treatment of spontaneous bleeds and for coverage during surgery in patients with haemophilia and inhibitors (antibodies) against factor VIII (FVIII) and factor IX (FIX) (haemophilia A and B with inhibitors) and NovoThirteen® for FXIII congenital deficiency, a very rare and serious bleeding disorder with limited treatment options. Molecules in the clinical development pipeline include N8-GP, designed to provide a longer half-life and the potential to reduce the treatment burden for people with haemophilia A and N9-GP, a long-acting recombinant factor IX for haemophilia B that has the potential to significantly reduce bleeding with weekly injections.
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.
Globally, it is estimated that 420,000 people have haemophilia.7 The disease is severely under-diagnosed in developing countries.
Novo Nordisk is a focused healthcare company.
Novo Nordisk is a healthcare company and a world leader in diabetes care.
In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society.
SOURCE: Novo Nordisk
Post Views: 30
COPENHAGEN, Denmark I May 12, 2014 I Today, Novo Nordisk announced new phase 3 interim data from its guardianT2 trial for its recombinant coagulation factor VIII (rFVIII) product NovoEight® (turoctocog alfa), the first new rFVIII molecule in over a decade, which shows that it provides long-term reduction from bleeding in people with haemophilia A when used as a preventative treatment.1 The results were presented at the World Federation of Haemophilia (WFH) World Congress and support findings from other studies within the guardianT clinical programme that found NovoEight® demonstrated good efficacy in preventing and treating bleeds without inhibitor development in previously treated patients.2,3
Commenting on the results, Dr Margareth Ozelo, Hemocentre, IHTC, University of Campinas, Sao Paulo, Brazil and guardianT2 investigator said, “As a physician treating haemophilia A, having another FVIII product available is good news and can lead to improved treatment outcomes and quality of life for our patients. Reducing the number of bleeding episodes is a key consideration as they are very painful and frightening for patients and caregivers and can lead to severe long-term joint damage or arthropathy.”
NovoEight® has been carefully designed using advanced protein and purification technology to provide a reliable and portable treatment option for people with haemophilia A combined with a good safety profile.4 NovoEight® offers convenient and flexible storage requirements and can be stored at 30?C/86?F for 6 months giving patients the freedom to administer whenever and wherever needed.5,6
Phase 3 guardianT2 results:
GuardianT2 is the extension of the pivotal guardianT clinical programme, one of the largest and most comprehensive pre-registration clinical trial programmes in haemophilia, with more than 210 severe haemophilia A patients treated. GuardianT2 is an open-label, multinational, single-arm extension trial involving 188 haemophilia A patients from 18 countries who had been previously enrolled in the guardianT1 and guardianT3 trials. Patients received NovoEight® in a preventative regimen and to treat breakthrough bleeds. Interim results found:1
. The overall estimated annual bleeding rate (ABR) achieved during preventative regimen with NovoEight® was 1.7 (median 3.1) bleeds/patient/year, ranging from 1.4 (children aged 0-5) to 1.9 for adults (median number of bleeds/patient/year)
. Preventative regimen with NovoEight® led to a decrease in ABR, followed by stabilisation at a lower level over the time period assessed.
About NovoEight®
NovoEight® has been approved by the FDA (October 2013) and EMA (November 2013) for the treatment and prophylaxis of bleeding in patients with haemophilia A. NovoEight® has also been approved in Japan and Australia (January 2014) and in Switzerland (February 2014) and applications for regulatory approvals have been submitted in a range of other countries.
Novo Nordisk in Haemophilia
In addition to NovoEight®, Novo Nordisk has developed a comprehensive portfolio of molecules aimed at improving haemophilia treatment. Marketed products include NovoSeven® for the treatment of spontaneous bleeds and for coverage during surgery in patients with haemophilia and inhibitors (antibodies) against factor VIII (FVIII) and factor IX (FIX) (haemophilia A and B with inhibitors) and NovoThirteen® for FXIII congenital deficiency, a very rare and serious bleeding disorder with limited treatment options. Molecules in the clinical development pipeline include N8-GP, designed to provide a longer half-life and the potential to reduce the treatment burden for people with haemophilia A and N9-GP, a long-acting recombinant factor IX for haemophilia B that has the potential to significantly reduce bleeding with weekly injections.
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.
Globally, it is estimated that 420,000 people have haemophilia.7 The disease is severely under-diagnosed in developing countries.
Novo Nordisk is a focused healthcare company.
Novo Nordisk is a healthcare company and a world leader in diabetes care.
In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society.
SOURCE: Novo Nordisk
Post Views: 30
