NovoSeven(R) Resolved 96.5% of Bleeds When Initiated Within One Hour After Bleed Onset in People With Haemophilia A or B With Inhibitors

PR66755

BAGSVAERD, Denmark, Dec. 4, 2016 /PRNewswire=KYODO JBN/

     This material is intended for global medical media only.

    For journalistic assessment and preparation before publication.

    Novo Nordisk today announced that NovoSeven(R) (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(R) 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(R) (less than or equal to 1 hour, greater than 1 to less than or

equal to 4 hours, greater than 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(R) 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(R) (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(R) for a decreased therapeutic response.[1]

    About NovoSeven(R)

    NovoSeven(R) 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(R) 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

[https://www.facebook.com/novonordisk ], Twitter

[https://twitter.com/novonordisk ], LinkedIn

[https://www.linkedin.com/company/novo-nordisk ], YouTube

[https://www.youtube.com/user/novonordisk/custom ]

    Further information

    Media:       

    Katrine Sperling    

    +45 4442 6718    

    krsp@novonordisk.com

    Asa 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 Ogren    

    +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(R) 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).

SOURCE: Novo Nordisk