Novo Nordisk recently announced the launch of Novoeight®, the company’s new recombinant factor VIII therapy. The product is approved by the US Food and Drug Administration 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.
Approval of Novoeight® is based on results from a large set of clinical studies known as the guardian™ trials. 91% of bleeds experienced by patients in the guardian™1 and guardian™3 trials were controlled with one or two 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%).
According to Novo Nordisk press release, the product can be stored at 86 degrees Fahrenheit for up to 12 months and can be kept at that temperature for up to four hours after reconstitution. It was shown to be safe and effective in clinical trials with zero inhibitors confirmed in 213 previously treated patients with hemophilia A.
“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.”
Novo Nordisk plans to make Novoeight® available by mid-April 2015.
Source: Novo Nordisk news release dated March 26, 2015
