Baxter International Inc. (BAX) said the United States Food and Drug Administration has approved Rixubis for routine prophylactic treatment, control of bleeding episodes, and perioperative management in adults with hemophilia B.
Rixubis is the first new recombinant factor IX or rFIX approved for hemophilia B in more than 15 years. It is the only rFIX indicated for both routine prophylaxis and control of bleeding episodes in the U.S. for adult patients living with this chronic condition.
Hemophilia B is the second most common type of hemophilia. It is the result of insufficient amounts of clotting factor IX, a naturally occurring protein in blood that controls bleeding.
The approval is based on a Phase I/III study demonstrating that twice-weekly prophylactic treatment with Rixubis for six months achieved a median annualized bleed rate or ABR of 2.0 with 43 percent of patients experiencing no bleeds.
In this study, no patients developed an inhibitory antibody to FIX and no cases of anaphylaxis were reported. One patient developed a transient antibody to furin.
by RTT Staff Writer
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