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SILVER SPRING, Md. — The Food and Drug Administration has approved what's being called the first therapy of its kind to prevent bleeding episodes.
The FDA announced Thursday the approval of Westlake Village, Calif.-based Baxter Healthcare Corp.'s Rixubis (coagulation factor IX [recombinant]) for patients with hemophilia B age 16 years and older. The treatment is used for controlling and preventing bleeding episodes, management of patients after surgery and routine use to prevent or reduce the frequency of bleeding episodes.
Hemophilia B affects about 3,300 people in the United States, mostly males, and can cause potentially serious bleeding, mainly in the joints, thus destroying the joints.
"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," FDA Center for Biologics Evaluation and Research director Karen Midthun said.