Novo Nordisk to Launch Novoeight® in the United States for People With Hemophilia A

News provided by

Mar 26, 2015, 12:47 ET

PLAINSBORO, N.J., March 26, 2015 /PRNewswire/ -- Novo Nordisk today announced the company will launch Novoeight^® (Antihemophilic Factor [Recombinant]) in the United States for people living with hemophilia A. Novoeight^® offers purity, reliability, and enhanced portability, with the highest storage temperature for the longest period of time compared with other marketed recombinant Factor VIII products—up to 86 degrees F for 12 months.¹ It can be kept at that temperature for up to 4 hours after reconstitution, giving it the longest postreconstitution storage time.¹Novoeight^® offers purity through a 5-step purification process. It was shown to be safe and effective in clinical trials with zero inhibitors confirmed in 213 previously treated patients with hemophilia A.¹Novo Nordisk plans to make Novoeight^® available by mid-April 2015.

"Hemophilia patients have unique, individualized needs, so it is critical for them to have access to different therapies," said Roshni Kulkarni, MD, Professor of Pediatric Hematology/Oncology and Director of Pediatrics at the Centers for Bleeding and Clotting Disorders, Michigan State University. "Today's patients are looking for options that fit into their busy lives, and it's encouraging to see new treatment options that further serve patients within the bleeding disorders community."

The US Food and Drug Administration (FDA) approved Novoeight^®for use in adults and children with hemophilia A for the control and prevention of bleeding, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes based on results from the guardian™ trials—one of the largest and most comprehensive clinical trial programs of a recombinant Factor VIII to date.¹

"Novoeight^® is the latest hemophilia therapy from Novo Nordisk to build on the company's long-standing heritage in rare bleeding disorders, which began with the development of its first recombinant factor therapy more than 20 years ago," said Stephanie Seremetis, M.D., CMO and CVP, Hemophilia, Novo Nordisk. "We have applied our deep understanding of the challenges faced by people living with hemophilia when creating Novoeight^®."

Ninety-one percent of bleeds experienced by patients in the guardian™1 and guardian™3 trials were controlled with 1 or 2 doses.¹Patients who took Novoeight^® prophylactically had a median of 3.1 bleeds per year.¹ Some patients from those trials continued prophylaxis with Novoeight^® in a safety extension trial. An interim analysis as of September 1, 2012, showed that these patients had a median of 1.7 bleeds per year.^2,3The most common adverse reactions were injection site reactions (2.3%), increased hepatic enzymes (1.4%), and pyrexia (0.9%).¹

Novo Nordisk is confident in the Novoeight^®offering and is supporting eligible patients who try the product with a satisfaction guarantee. For more information, visit www.novoeight.com.

Indications and Usage for Novoeight^® (Antihemophilic Factor [Recombinant])
Novoeight^® 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 for Novoeight^®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 hemophilia A
Hemophilia A, also called Factor VIII deficiency or classic hemophilia, is a genetic disorder caused by missing or defective Factor VIII, a clotting protein.⁴ Although it is usually passed down from parents to children, about one-third of cases are caused by a spontaneous mutation, which is a change in a gene.⁴

According to the US Centers for Disease Control and Prevention, hemophilia occurs in approximately 1 in 5,000 live births.⁴ There are about 20,000 people with hemophilia in the United States.⁴ All races and ethnic groups are affected.⁴ Hemophilia A is 4 times as common as hemophilia B, and more than half of patients with hemophilia A have the severe form of hemophilia.⁴

About Novoeight^®
Novoeight^®is approved by the FDA (October 2013) and the European Medicines Agency (November 2013) for the treatment and prophylaxis of bleeding in patients with hemophilia A. Novoeight^®also is 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™
Three trials have been conducted to evaluate the safety and efficacy of Novoeight^®. guardian™1 enrolled adults and adolescents, and guardian™3 enrolled children. Upon completion of the initial trials, patients from both guardian™1 and guardian™3 were eligible to participate in the guardian™2 extension trial. Data from guardian™1 and guardian™3 as well as data from the first part of the guardian™2 extension trial were analyzed at the time of submission for approval and showed a median annualized bleeding rate (ABR) of 3.1 in 213 adults, adolescents, and children treated with Novoeight^® prophylaxis. In addition, an interim analysis as of September 1, 2012, on 188 patients who continued to receive treatment in the ongoing guardian™2 trial was presented at the World Federation of Hemophilia 2014 World Congress and showed a median ABR of 1.7.

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 hemophilia care, growth hormone therapy, and hormone replacement therapy. Novo Nordisk employs approximately 41,500 employees in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, or YouTube.

References
1.    Novoeight^® (Antihemophilic Factor [Recombinant]) Prescribing Information. September 2014.
2.    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.
3.    Data on file. Novo Nordisk Inc; Plainsboro, NJ.
4.    National Hemophilia Foundation. Bleeding Disorders. Types of Bleeding Disorders. Hemophilia A. https://www.hemophilia.org/Bleeding-Disorders/Types-of-Bleeding-Disorders/Hemophilia-A. Accessed February 12, 2015.

SOURCE Novo Nordisk