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NovoSeven® resolved 96.5% of bleeds when initiated
within one hour after bleed onset in people with
haemophilia A or B with inhibitors
Bagsværd, Denmark, 3 December 2016 – Novo Nordisk today announced that
NovoSeven® (rFVIIa), a portable room temperature stable recombinant activated factor
VIIa, resolved 96.5% of bleeds when initiated within one hour after onset of bleeding,
demonstrating efficacy of early treatment in people with haemophilia A or B with
inhibitors.1 Efficacy also remained high for bleeds treated after 4 hours.1 A subanalysis of
the SMART-7™ study, evaluating the efficacy of NovoSeven® in a real-world setting, was
presented today at the 58th American Society of Haematology (ASH) annual meeting.
The SMART-7™ study examined the status of bleeding episodes across people with
haemophilia divided into three groups by time to first treatment with NovoSeven® (≤1
hour, ˃1‒≤4 hours, ˃4 hours).1 Across the three groups, 94.6% of bleeds were resolved
while another 4.8% of bleeds were slowed.1
“Clinical guidelines recommend that acute bleeds in people with haemophilia should be
treated within two hours of bleed onset,” said Dr Gary Benson, SMART-7™ investigator,
Northern Ireland Haemophilia Comprehensive Care Centre, Belfast City Hospital, Belfast,
®
UK. “This study has shown that NovoSeven has a favourable safety profile and can help
people living with haemophilia to address bleeds quickly.”
Efficacy results from this subgroup analysis of SMART-7™ are aligned with previous
rFVIIa data.2-7 Furthermore, no binding antibodies were associated with the room
temperature stable formulation of rFVIIa under real-world conditions.
About SMART-7™
SMART-7™ (NCT01220141) was a prospective, post-authorisation, single-arm,
multinational, multi-centre, non-interventional study investigating the safety and
effectiveness of NovoSeven® (rFVIIa), a room temperature stable recombinant activated
factor VIIa in people with haemophilia A or B with inhibitors in a real-world setting.1
A total number of 51 participants were enrolled across 14 countries. Participants were
aged 1.6–69.5 years (median 22.0 years) with a historical median bleeding rate of one
Novo Nordisk A/S
Corporate Communications
Novo Allé
2880 Bagsværd
Denmark
Telephone:
+45 4444 8888
Internet:
www.novonordisk.com
CVR no:
24 25 67 90
ZINC#: HQMMA/N7/1116/0153: November 2016
Page 2 of 3
episode per month. The primary objective of the study was to monitor people with
®
haemophilia A or B with inhibitors treated with NovoSeven for a decreased therapeutic
1
response.
®
About NovoSeven
®
NovoSeven is a recombinant activated factor VII (rFVIIa) and is indicated for the
treatment of spontaneous and surgical bleedings in haemophilia A or B patients with
inhibitors, acquired haemophilia, congenital FVII deficiency and Glanzmann’s
thrombasthenia (EU and US only).8
About haemophilia
Haemophilia is a chronic, inherited bleeding disorder that primarily affects males. People
born with haemophilia have little or no clotting factor, which is a protein needed for
normal blood clotting. The two main types of haemophilia are A and B; people living with
haemophilia A lack clotting factor VIII and people living with haemophilia B lack clotting
factor IX. Haemophilia A is about four times as common as haemophilia B.9 Inhibitor
formation is the most serious complication in haemophilia A or B, rendering the patient
unresponsive of replacement therapy with clotting factor VIII or IX. In that case,
®
bypassing agents such as NovoSeven are used.
Haemophilia can be mild, moderate or severe, depending on the amount of clotting factor
in the blood. Approximately 400,000 people are estimated to live with haemophilia
globally.10
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 42,600 people in 75 countries and markets its products
in more than 180 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn,
YouTube
Further information
Media:
Katrine Sperling
Åsa Josefsson
Novo Nordisk A/S
Corporate Communications
+45 4442 6718
+45 3079 7708
Novo Allé
2880 Bagsværd
Denmark
[email protected]
[email protected]
Telephone:
+45 4444 8888
Internet:
www.novonordisk.com
CVR no:
24 25 67 90
ZINC#: HQMMA/N7/1116/0153: November 2016
Page 3 of 3
Investors:
Peter Hugreffe Ankersen
+45 3075 9085
[email protected]
Melanie Raouzeos
+45 3075 3479
[email protected]
Anders Mikkelsen
+45 3079 4461
[email protected]
Hannah Ögren
+45 3075 8519
[email protected]
Kasper Veje (US)
+1 609 235 8567
[email protected]
_____________________
References
1. Benson, G. et al. Benefit of early treatment with Room Temperature Stable Recombinant
Activated Factor VII (rFVIIa) in patients with Hemophilia A or B with inhibitors: Subgroup
Analysis from the Prospective, Post-Authorization, Non-interventional SMART-7™ Study.
Poster number 1439. 58th American Society of Haematology (ASH) annual meeting. 3
December 2016.
2. Lusher JM. Eur J Haematol 1998;61(suppl 63):7–10.
3. Santagostino E, et al. Blood Rev 2015;29(suppl 1):S9–18.
4. Santagostino E, et al. J Thromb Haemost 2006;4(2):367–71.
5. Young G, et al. Haemophilia. 2008 Mar;14(2):287–94.
6. Kavakli K, et al. Thromb Haemost 2006;95(4):600–5.
7. Lentz SR, et al. J Thromb Haemost 2014;12(8):1244–53.
8. NovoSeven® Summary of Product Characteristics.
9. National Heart Lung and Blood Institute. What is hemophilia?
https://www.nhlbi.nih.gov/health/health-topics/topics/hemophilia (last accessed October
2016).
10. National Hemophilia Foundation. Fast Facts. http://www.hemophilia.org/About-Us/FastFacts (last accessed November 2016).
Novo Nordisk A/S
Corporate Communications
Novo Allé
2880 Bagsværd
Denmark
Telephone:
+45 4444 8888
Internet:
www.novonordisk.com
CVR no:
24 25 67 90
ZINC#: HQMMA/N7/1116/0153: November 2016