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. It can be kept at that temperature for up to 4 hours after reconstitution, giving it the longest postreconstitution storage time. Novoeight® 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. Novo 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.
"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™ and guardian™ trials were controlled with 1 or 2 doses. Patients who took Novoeight® prophylactically had a median of 3.1 bleeds per year. 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. The most common adverse reactions were injection site reactions (2.3%), increased hepatic enzymes (1.4%), and pyrexia (0.9%).