Novo Nordisk Launches Novoeight for Hemophilia A in the U.S.

Novo Nordisk has launched Novoeight (antihemophilic factor [recombinant]) in the U.S. for people living with hemophilia A. Compared with other recombinant factor VIII products, Novoeight offers purity through a five-step purification process and enhanced portability. It can also be kept at the highest storage temperature for the longest period of time (up to 86 degrees Fahrenheit for 12 months). And, it can be kept at that temperature for up to four hours after reconstitution, giving it the longest postreconstitution storage time. The product was shown to be safe and effective in clinical trials with zero inhibitors confirmed in 213 previously treated patients with hemophilia A.

The U.S. Food and Drug Administration 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. Ninety-one percent of bleeds experienced by patients in the guardian 1 and guardian 3 trials were controlled with one or two doses of Novoeight. Patients who took Novoeight prophylactically had a median of 3.1 bleeds per year. Patients from those trials who continued prophylaxis with Novoeight in a safety extension trial had a median of 1.7 bleeds per year. The most common adverse reactions were injection site reactions (2.3 percent), increased hepatic enzymes (1.4 percent) and pyrexia (0.9 percent).