FDA Approves Baxter’s Hemophilia B Drug ‘Rixubis’

The U.S. Food and Drug Administration on Thursday approved Baxter's new drug Rixubis for use in people with hemophilia B  and who are above 16 years of age.

The new drug Rixubis can be used to  control and prevent bleeding episodes, in perioperative management that is right from hospitalization to discharge and in regular use to avoid or decrease the incidence of bleeding events known as prophylaxis.

"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," said Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research. "This approval provides patients and physicians with an alternative treatment option to prevent or reduce the frequency of bleeding episodes."

 Hemophilia B is a blood clotting disorder that is triggered by the mutation of the Factor IX gene. In the United States nearly 3,300 people are affected with this clotting disorder. People suffering from Hemophilia B have the tendency to experience serious bleeding episodes especially in the joints that can be damaged with such frequent bleeding.

The newly approved drug 'Rixubis' is a purified protein that is produced by recombinant DNA technology. This drug lacks human or animal protein and is produced by single -use vials of freeze-dried powder. This is injected twice weekly after it is combined with sterilized water.

The effectiveness of the drug was tested in a multicenter study that was conducted on 73 males between ages 12-65. They were given Rixubis for routine prophylaxis. Researchers noticed that after being treated with the new drug the annual bleeding rate dropped by 75 percent when compared to those who received other treatments.

The serious side effect of this drug is anaphylaxis that is a life threatening allergic reaction.  Other common side effects include distorted taste, extreme pain and atypical blood test results.