BAGSVÆRD, Denmark, December 3, 2016 /PRNewswire/ --
This material is intended for global medical media only.
For journalistic assessment and preparation before
publication.
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 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, Facebook, Twitter, LinkedIn, YouTube
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
- 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.
- Lusher JM. Eur J Haematol 1998;61(suppl 63):7-10.
- Santagostino E, et al. Blood Rev 2015;29(suppl 1):S9-18.
- Santagostino E, et al. J Thromb Haemost 2006;4(2):367-71.
- Young G, et al. Haemophilia. 2008 Mar;14(2):287-94.
- Kavakli K, et al. Thromb Haemost 2006;95(4):600-5.
- Lentz SR, et al. J Thromb Haemost 2014;12(8):1244-53.
- NovoSeven® Summary of Product Characteristics.
- National Heart Lung and Blood Institute. What is hemophilia?
https://www.nhlbi.nih.gov/health/health-topics/topics/hemophilia
(last accessed October 2016).
- National Hemophilia Foundation. Fast Facts.
http://www.hemophilia.org/About-Us/Fast-Facts (last accessed
November 2016).