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New Hemophilia Treatment Set for April Launch
Novo Nordisk has announced plans to launch Novoeight (antihemophilic factor [recombinant]) in the U.S. by mid-April 2015 for people with hemophilia A.
According to the company, Novoeight offers the highest storage temperature for the longest period compared with other marketed recombinant factor VIII products — up to 86oF for 12 months. It can be kept at that temperature for up to 4 hours after reconstitution, giving it the longest post-reconstitution 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 FDA approved Novoeight in October 2013 for use in adults and children with hemophilia A for the control and prevention of bleeding, for perioperative management, and for routine prophylaxis to prevent or reduce the frequency of bleeding episodes, based on results from the pivotal GUARDIAN trials.
Ninety-one percent of bleeds experienced by patients in the GUARDIAN 1 and GUARDIAN 3 studies 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 events included injection-site reactions (2.3%), increased hepatic enzymes (1.4%), and pyrexia (0.9%).
Novoeight is not used to treat von Willebrand disease.
Source: Novo Nordisk; March 26, 2015.