Head-to-Head Trial Shows Refixia(R) Achieves Greater Total Factor IX Exposure in People With Haemophilia B Than Recombinant Factor IX-Fc Fusion Protein

PR73636

GLASGOW, Scotland, May 21, 2018, /PRNewswire=KYODO JBN/--

Adults with haemophilia B who received a single dose Refixia(R)(nonacog beta

pegol; N9-GP) achieved greater total factor IX exposure than those treated with

rFIXFc (recombinant factor IX-Fc fusion protein). The head-to-head paradigm7

trial also observed a longer half-life for Refixia(R). These pharmacokinetic

findings were presented today at the WFH 2018 World Congress in Glasgow, UK.1

The trial showed that the total factor IX exposure of Refixia(R) in patient

plasma after injection of a single dose (50 IU/kg) was 4.39-fold greater than

for rFIXFc, as measured by the area under the curve (AUC). Seven days after

injection, the factor IX activity in patients treated with a single dose of

Refixia(R) was six-fold greater than that of patients treated with rFIXFc at

the same dose.

"As a clinician, I know first-hand how challenging it can be to help people

living with haemophilia B reach their treatment goals and be adequately

protected from bleeding" said Dr Carmen Escuriola Ettingshausen of the

Rhein-Main Haemophilia Centre (HZRM), Germany. "These data will help us better

understand the different treatment options and choose the appropriate treatment

for each patient."

The half-life of Refixia(R) in the trial was 103.2 hours, significantly longer

than the half-life of rFIXFc (84.9 hours). In addition, total factor IX

activity levels 30 mins after infusion were two-fold greater with Refixia(R)

compared to rFIXFc. No patients developed inhibitors and no safety concerns

were identified during the trial.

"People with haemophilia B and their clinicians want to be confident that they

are protected from bleeds without worrying" said Mads Krogsgaard Thomsen,

executive vice president and chief science officer of Novo Nordisk. "These

head-to-head data support the strong clinical profile of Refixia(R) which can

provide an alternative treatment option for people with haemophilia B with the

convenience of a single weekly dose."

About the paradigm7 trial

Paradigm7 was a multicentre, open-label, randomised, crossover, pharmacokinetic

trial in 15 previously treated adult males with congenital haemophilia B

(factor IX activity less than or equal 2%), conducted in three countries (US, Germany,

Switzerland). Patients received single injections (50 IU/kg) of Refixia(R) and

rFIXFc with greater than or equal 21 days between doses. The primary endpoint was

dose-normalised area under the factor IX activity-time curve from 0 to infinity

(AUC0-inf,norm).

About Refixia(R)  

Refixia(R)(nonacog beta pegol; N9-GP) is an extended half-life factor IX

molecule for replacement therapy in patients with haemophilia B.2 The review of

Refixia(R) was based on the paradigm clinical programme. In the completed phase

3 trials, 115 previously treated patients had a total of more than 8,800

exposure days for up to 2.7 years of treatment with Refixia(R).

About haemophilia B

Haemophilia is a chronic, inherited bleeding disorder that primarily affects

males. People with haemophilia B have congenital factor IX deficiency and are

either missing or have a malfunctioning factor IX protein, which is needed for

proper blood clotting.3

Globally it is estimated that 30,000 people have been diagnosed with

haemophilia B. The disease is severely underdiagnosed in some regions of the

world.4

About Novo Nordisk

Novo Nordisk is a global healthcare company with 95 years of innovation and

leadership in diabetes care. This heritage has given us experience and

capabilities that also enable us to help people defeat obesity, haemophilia,

growth disorders and other serious chronic diseases. Headquartered in Denmark,

Novo Nordisk employs approximately 42,700 people in 79 countries and markets

its products in more than 170 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].   

References

1.    Escuriola Ettingshausen C, Hegemann I, Simpson M, et al. A head-to-head

pharmacokinetic comparison of N9-GP and rFIXFc in patients with haemophilia B.

Presented at the WFH 2018 World Congress, Glasgow, UK, 20-24 May. 2018

2.    EMA. Refixia(R). Summary of Product Characteristics. Available at:

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004178/WC500232816.pdf.

Last accessed: April 2018.

3.    Srivastava A, Brewer AK, Mauser-Bunschoten EP, et al. Guidelines for the

management of hemophilia. Haemophilia. 2013;19:e1-47

4.    National Hemophilia Foundation. Fast Facts. Available at:

http://www.hemophilia.org/About-Us/Fast-Facts. Last accessed: April 2018.

Further Information

Media:

Katrine Sperling        +45-4442-6718  krsp@novonordisk.com

Asa Josefsson           +45-3079-7078  aajf@novonordisk.com

Investors:

Peter Hugreffe Ankersen +45-3075-9085  phak@novonordisk.com

Anders Mikkelsen        +45-3079-4461  armk@novonordisk.com

Christina Kjaer          +45-3079-3009  cnje@novonordisk.com

Source: Novo Nordisk