In a Phase 3 Trial, Novoeight®(Antihemophilic Factor [Recombinant]) Provided Long-term Efficacy and Safety in the Prophylaxis and Treatment of Bleeds in People with Hemophilia A

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Jun 24, 2015, 07:30 ET

TORONTO, June 24, 2015 /PRNewswire/ --

Today, at the International Society on Thrombosis and Haemostasis (ISTH) 2015 Congress, Novo Nordisk announced the latest interim data from the guardian™2 extension trial, which showed that in a phase 3 trial, Novoeight^® (Antihemophilic Factor [Recombinant]) provided long-term efficacy and safety in the prophylaxis and treatment of bleeds in people with severe hemophilia A.^[¹^]

The pivotal guardian™ clinical program was one of the largest and most comprehensive preregistration clinical trial programs in hemophilia A, with more than 210 patients with severe hemophilia A treated. Interim data collected through December 31, 2013, from 451.6 patient-years on Novoeight^® show results consistent with previous reports:

The overall estimated median annual bleeding rate (ABR) achieved during the preventive regimen with Novoeight^® was 1.56^[¹^]
During the preventive regimen, 90% of all bleeding episodes were successfully treated with 1 or 2 injections of Novoeight^® ^[¹^]

"These interim results provide an extension to the body of evidence supporting the long-term use of Novoeight^®," said Dr. Margareth Ozelo, IHTC Hemocentro Unicamp, University of Campinas, Sao Paulo, Brazil, and guardian™2 investigator. "For people with hemophilia A, finding treatments that are effective at preventing bleeding episodes long-term is essential."

Guardian™2 is a large, multinational extension trial of Novoeight^® in previously treated patients with hemophilia A from 19 countries who had been enrolled in the pivotal guardian™1 and guardian™3 trials.^[¹^] Patients received Novoeight^® in a prophylactic regimen and to treat breakthrough bleeds.^[¹^]

These findings now comprise more than 4 years of data and more than 450 patient- years. No inhibitors to factor VIII were detected and no safety issues were identified, supporting the findings from guardian™1 and 3 demonstrating no confirmed inhibitor development in 213 previously treated patients. The most common adverse reactions (≥0.5%) seen in the study were injection site reactions, increased hepatic enzymes, and fever.^[²^]

Indications and Usage

Novoeight^® (Antihemophilic Factor [Recombinant]) is an injectable medicine used to control and prevent bleeding in people with hemophilia 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 a B-domain truncated recombinant human coagulation factor VIII for the treatment and prevention of bleeding in patients with hemophilia A. Novoeight^® has been launched in 11 countries including the United States (April 2015) and Japan (May 2014).

About Hemophilia A

Hemophilia is a chronic, inherited bleeding disorder that primarily affects males. People with hemophilia A are either missing or have a malfunctioning factor VIII protein, which is essential for proper blood clotting. People with hemophilia A have a tendency to bleed longer than most or to bleed internally into joints, muscles, or organs because they are missing this clotting factor. To manage the disease and stop bleeding, people with hemophilia A must replace the missing factor VIII protein, which is accomplished by intravenous injection of the clotting factor.^[³^]

Globally, it is estimated that 142,000 people have been diagnosed with hemophilia A.^[⁴^]The disease is severely underdiagnosed in developing countries.

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: hemophilia, growth disorders, and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 39,000 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, or YouTube.

References

Lentz S, Kempton CL, Janic D, et al. Interim results from a large multinational extension trial (guardian™2) using turoctocog alfa for prophylaxis and treatment of bleeding in patients with severe haemophilia A. Abstract presented at: International Society on Thrombosis and Haemostasis (ISTH) 2015 Congress; June 20-25, 2015; Toronto, Canada.
Novoeight [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2015.
Srivastava A, Brewer AK, Mauser-Bunschoten EP, et al; Treatment Guidelines Working Group on Behalf of the World Federation of Hemophilia. Guidelines for the management of hemophilia. Haemophilia. 2013;19(1):e1-e47.
World Federation of Hemophilia. Report on the Annual Global Survey 2012. Published by World Federation of Hemophilia: Montreal, Canada; 2013.

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