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 (ots/PRNewswire) -

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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(TM)
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(TM) 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(TM) 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(TM) 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(TM)

SMART-7(TM) (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 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 response.[1]

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 (http://www.novonordisk.com/), Facebook
(http://www.facebook.com/novonordisk), Twitter
(http://www.twitter.com/novonordisk), LinkedIn
(http://www.linkedin.com/company/novo-nordisk), YouTube
(http://www.Youtube.com/novonordisk)

Further information
Media:

Katrine Sperling

+45 4442 6718

krsp@novonordisk.com

Åsa Josefsson

+45 3079 7708

aajf@novonordisk.com

Investors:

Peter Hugreffe Ankersen

+45 3075 9085

phak@novonordisk.com

Melanie Raouzeos

+45 3075 3479

mrz@novonordisk.com

Anders Mikkelsen

+45 3079 4461

armk@novonordisk.com

Hannah Ögren

+45 3075 8519

haoe@novonordisk.com

Kasper Veje (US)

+1 609 235 8567

kpvj@novonordisk.com

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(TM) 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/Fast-Facts (last accessed
November 2016).

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