FDA backs Baxter's Rixubis for hemophilia B; Breakthrough status for GSK's drisapersen

The US Food and Drug Administration yesterday (June 27) approved Baxter International’s (NYSE: BAX) Rixubis (coagulation Factor IX [recombinant]) for use in people with hemophilia B who are 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). The product was granted orphan status by the FDA and Baxter says it plans to apply for marketing authorization in the European Union later this year.

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 USA. Individuals with hemophilia B can experience potentially serious bleeding, mainly into the joints, which can be destroyed by such bleeding.

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