Making it the first new recombinant factor IX approved for hemophilia B in more than 15 years, FDA has approved Baxter International’s Rixubis for use in hemophilia B patients 16 and up.

Rixubis, which is indicated for the control and prevention of bleeding episodes, perioperative management, and routine use to prevent or reduce the frequency of bleeding episodes (prophylaxis), is a purified protein produced by recombinant DNA technology.

Its efficacy was evaluated in a multicenter study involving 73 male patients between 12 and 65, who received Rixubis on demand for routine prophylaxis or as needed in response to symptoms of bleeding. “Overall, patients in the prophylaxis study had a 75% lower annual bleeding rate when compared to patients who have historically received on-demand treatment,” FDA noted, adding that an additional study in a pediatric population is ongoing.

“As the first recombinant coagulation factor IX indicated specifically for routine prophylaxis to prevent bleeding, Rixubis becomes a new weapon in our arsenal to protect Hemophilia B patients,” Karen Midthun, M.D., director of FDA’s Center for Biologics Evaluation and Research, said in a statement. “This approval provides patients and physicians with an alternative treatment option to prevent or reduce the frequency of bleeding episodes.”

In a Baxter statement, Val Bias, chief executive officer of the National Hemophilia Foundation, said: “Baxter has long been a leader in the support of people living with bleeding disorders with its innovative products and programs. We applaud their ongoing commitment to the hemophilia community, demonstrated once again with now the first prophylactic treatment approved in the U.S. for adults living with hemophilia B.”

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