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Novo Nordisk introduces hemophilia therapy Novoeight in US

Danish pharmaceutical firm Novo Nordisk has introduced Novoeight (Antihemophilic Factor [Recombinant]) in the US for the treatment of people living with hemophilia A.

According to the company, Novoeight provides purity, reliability and improved 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.

The drug can be kept at that temperature for up to four hours after reconstitution, giving it the longest postreconstitution storage time.

In previous clinical trials, Novoeight was shown to be safe and effective with zero inhibitors confirmed in 213 previously treated patients with hemophilia A.

Novoeight offers purity through a 5-step purification process and the company intends to make the product available by mid-April 2015.

Michigan State University professor of Pediatric Hematology/Oncology and director of Pediatrics at the Centers for Bleeding and Clotting Disorders Roshni Kulkarni said: "Hemophilia patients have unique, individualized needs, so it is critical for them to have access to different therapies.

"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."

In the US, Novoeight is approved 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.