Regulatory Focus™ > News Articles > FDA Approves Baxter's Rixubis, First Recombinant Coagulation Factor IX for Hemophilia B

FDA Approves Baxter's Rixubis, First Recombinant Coagulation Factor IX for Hemophilia B

Posted 28 June 2013 | By Louise Zornoza 

The US Food and Drug Administration (FDA) yesterday approved Baxter Healthcare's Rixubis [Coagulation Factor IX (Recombinant)] for use in people with hemophilia B who aged 16 or 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. It affects about 3,300 people in the US, and can lead to potentially serious bleeding, mainly into 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," said Karen Midthun, 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. 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.

 

FDA Approval Notice

Read all Breaking News from RegLink


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe