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FDA NEWS RELEASE

 
For Immediate Release: June 27, 2013
Media Inquiries: Curtis Allen, 301-796-4030,curtis.allen@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA, OCOD@fda.hhs.gov
 

FDA approves first recombinant coagulation factor IX that is specifically indicated for routine use in preventing bleeding episodes (prophylaxis) 

 
The U.S. Food and Drug Administration yesterday approved Rixubis [Coagulation Factor IX (Recombinant)] for use in people with hemophilia B who are 16 years of age and older. Rixubis is indicated for the control and prevention of bleeding episodes, perioperative (period extending from the time of hospitalization for surgery to the time of discharge) management, and routine use to prevent or reduce the frequency of bleeding episodes (prophylaxis).
 
An inherited blood clotting disorder mainly affecting males, Hemophilia B is caused by mutations in the Factor IX gene and leads to deficiency of Factor IX. Hemophilia B affects about 3,300 people in the United States. Individuals with Hemophilia B can experience potentially serious bleeding, mainly into the joints, which can be destroyed by such bleeding.
 
“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.”
 
Rixubis is a purified protein produced by recombinant DNA technology. It does not contain human or animal proteins. It is supplied in single-use vials of freeze-dried powder and is administered by intravenous injection after reconstitution with sterile water for injection. When used for the routine prevention of bleeding episodes, it is administered twice weekly.
 
The efficacy of Rixubis was evaluated in a multicenter study in which a total of 73 male patients between 12 and 65 years of age received Rixubis for routine prophylaxis or as needed in response to symptoms of bleeding (on-demand). Overall, patients in the prophylaxis study had a 75 percent lower annual bleeding rate when compared to patients who have historically received on-demand treatment. An additional study in a pediatric population is currently ongoing.
 
Although serious side effects including anaphylaxis (life-threatening allergic reactions) can occur, the most common side effects observed in patients in clinical studies were dysgeusia (distorted taste), pain in an extremity, and atypical blood test results.
 
Rixubis is manufactured by Baxter Healthcare Corporation, Westlake Village, Calif.
 
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
 
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Page Last Updated: 06/27/2013
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