Baxter Files Rixubis in EU

Baxter International has submitted an MAA to the EMa for approval of Rixubis, recombinant factor IX (nonacog gamma) for the treatment and prophylaxis of bleeding in patients of all ages with hemophilia B. The filing is based on results of research with hemophilia B patients previously treated with other therapies.

Hemophilia B, also known as Christmas disease, is the second most common type of hemophilia and results from insufficient amounts of clotting factor IX, a naturally occurring protein in blood that helps to control bleeding. Rixubis was approved for adult patients and launched in the U.S. and Puerto Rico earlier in 2013.

A global Phase I/III study of adult patients with severe or moderately severe hemophilia B demonstrated that twice-weekly prophylactic treatment with RIXUBIS for six months achieved a median annualized bleed rate (ABR) of 2.0, with 43 percent (24/56) of patients experiencing no bleeds. In the study, no patients developed an inhibitory antibody to FIX and no cases of anaphylaxis were reported. The most common adverse reactions observed in >1% of subjects of this study were dysgeusia, and pain in extremity. The application is further supported by data from a study of 23 hemophilia B patients less than twelve years old.

In the U.S., Rixubis is an antihemophilic factor indicated for control and prevention of bleeding episodes in adults with hemophilia B, perioperative management in adults with hemophilia B, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia B. It is not indicated for induction of immune tolerance in patients with hemophilia B.