Novoeight® Phase 3 Data Show Reduction in Annualised Bleeding Rate Over Time in People With Haemophilia A

SAN FRANCISCO, December 7, 2014 /PRNewswire/ --

Today, Novo Nordisk announced a new analysis of phase 3 data demonstrating people with haemophilia A who had the highest annualised bleeding rate (ABR) during initial treatment with Novoeight^® (Antihemophilic Factor [Recombinant]) showed the largest reduction in bleeding over the duration of treatment. Data for the recombinant factor VIII (rFVIII) product Novoeight^® were presented at the 56^th Annual Meeting of the American Society of Hematology (ASH).^[1]

The post hoc analysis from the guardian™2 trial further found that, when continued on treatment with Novoeight^®, adults and adolescents showed reductions of 69% and 63%, respectively, in ABR compared with their ABRs from guardian™1. The guardian™1 trial (along with guardian™3) showed that Novoeight^® was efficacious in preventing and reducing bleeds with no confirmed inhibitor development in 213 previously treated patients.^[2],[3]

"This post hoc analysis gives an indication that patients with high baseline bleed rate can benefit from prophylaxis with Novoeight^®, as well as patients who maintain low ABR," said Margareth Ozelo, M.D., Ph.D., Hemocentre, IHTC, University of Campinas, Sao Paulo, Brazil, and lead investigator.

The most common adverse reactions (≥0.5%) seen in the study were injection site reactions, increased hepatic enzymes, and fever.^[4]

Indications and Usage 

Novoeight^® (Antihemophilic Factor [Recombinant]) is an injectable medicine used to control and prevent bleeding in people with haemophilia A. Your healthcare provider may give you Novoeight^® when you have surgery.

Novoeight^® is not used to treat von Willebrand Disease.

Important Safety Information 

You should not use Novoeight^® if you are allergic to factor VIII or any of the other ingredients of Novoeight^® or if you are allergic to hamster proteins.

Call your healthcare provider right away and stop treatment if you get any of the following signs of an allergic reaction: rashes or hives, difficulty breathing or swallowing, tightness of the chest, swelling of the lips and tongue, light-headedness, dizziness or loss of consciousness, pale and cold skin, fast heartbeat, or red or swollen face or hands.

Before taking Novoeight^®, you should tell your healthcare provider if you have or have had any medical conditions, take any medicines (including non-prescription medicines and dietary supplements), are nursing, pregnant or planning to become pregnant, or have been told that you have inhibitors to factor VIII.

Your body can make antibodies called "inhibitors" against Novoeight^®, which may stop Novoeight^® from working properly. Call your healthcare provider right away if your bleeding does not stop after taking Novoeight^®.

Common side effects of Novoeight^® include swelling or itching at the location of injection, changes in liver tests, and fever.

For full Prescribing Information, please click here .

About Novoeight^®
Novoeight^® is approved by the US Food and Drug Administration (October 2013) and the European Medicines Agency (November 2013) for the treatment and prophylaxis of bleeding in patients with haemophilia A. Novoeight^® is also approved in Japan (January 2014), Australia (January 2014), and Switzerland (February 2014), and applications for regulatory approvals have been submitted in a range of other countries.

About guardian™ 

The pivotal guardian™ clinical programme is one of the largest and most comprehensive preregistration clinical trial programmes in haemophilia, with more than 210 patients with severe haemophilia A treated. The guardian™2 trial is an extension of the clinical programme. The post hoc analysis of the guardian™2 trial involved 166 patients who had participated in guardian™2 and either guardian™1 or 3, had ≤1 week of surgery treatment in guardian™1 or 3 (initial period), and had ≥3 months of exposure to turoctocog alfa prophylaxis during a selected time period (1 January 2012-30 June 2013) in guardian™2.

About Haemophilia A 

Haemophilia is a chronic, inherited bleeding disorder that primarily affects males. People with haemophilia A are either missing or have a malfunctioning factor VIII protein, which is essential for proper blood clotting. People with haemophilia A have a tendency to bleed longer than most or to bleed internally into muscles, joints or organs because they are missing this clotting factor. To manage the disease and stop bleeding, people with haemophilia A must replace the missing factor VIII protein, which is accomplished by intravenous injection of the clotting factor.^[5]

Globally, it is estimated that more than 400,000 people have haemophilia.^[6] The disease is severely underdiagnosed in developing countries.

About Novo Nordisk 

Headquartered in Denmark, Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy. Novo Nordisk employs approximately 41,000 employees in 75 countries, and markets its products in more than 180 countries. For more information, visit http://novonordisk.com.

References 

1. Ozelo M. et al. Changes in annualized bleeding rate over time and relationship with dosing of turoctocog alfa during the guardian™ programme. Poster presentation #2850. 56^th Annual Meeting and Exposition of the American Society of Hematology. December 6-9, 2014.
2. Lentz SR. et al. Results from a large multinational clinical trial (guardian™1) using prophylactic treatment with turoctocog alfa in adolescent and adult patients with severe haemophilia A: safety and efficacy. Haemophilia. 2013;19(5):691-697.
3. Kulkarni R. et al. Results from a large multinational clinical trial (guardian™3) using prophylactic treatment with turoctocog alfa in paediatric patients with severe haemophilia A: safety, efficacy and pharmacokinetics. Haemophilia. 2013;19(5):698-705.
4. Novoeight^® (Antihemophilic Factor [Recombinant]) Prescribing Information. Plainsboro, NJ: Novo Nordisk Inc.; November 2014.
5. Srivastava A., et al. Guidelines for the management of hemophilia. Haemophilia. 2013;19(1):e1-e47.
6. National Hemophilia Foundation. Fast Facts. http://www.hemophilia.org/About-Us/Fast-Facts .

Further information
Media:
Katrine Sperling, +45-3079-6718, [email protected]
Ken Inchausti (US), +1-609-514-8316, [email protected]

Investors:
Kasper Roseeuw Poulsen, +45-3079-4303, [email protected]
Daniel Bohsen, +45-3079-6376, [email protected]
Melanie Raouzeos, +45-3075-3479, [email protected]

Frank Daniel Mersebach (US), +1-609-235-8567, [email protected]

SOURCE Novo Nordisk