JAPANESE REGULATORS APPROVE BAXTER'S ADVATE

Baxter announced that Japan's Ministry of Health, Labor and Welfare has approved Advate (rurioctocog alfa, recombinant, plasma/albumin free method) as a replacement therapy indicated for blood coagulation and to reduce the tendency to bleed for people with factor VIII deficiency (hemophilia A). Advate is the only recombinant factor VIII therapy processed without any added blood components.

All currently available factor VIII therapies use human or animal blood-derived components at various stages of processing, according to the company. Since the effectiveness of inactivation techniques cannot be guaranteed, one way to eliminate this potential risk for people with hemophilia is to remove these blood-based components from the factor VIII processing, Baxter said.

Advate will be available in Japan in three different potencies: 250 IU/vial, 500 IU/vial and 1,000 IU/vial. Advate is already approved in the U.S., Canada, Australia and 28 countries in Europe.