(By Balseshan) Baxter International Inc. (NYSE:BAX) said ADVATE (Recombinant Human Coagulation Factor VIII for injection) for the treatment of hemophilia A was approved in China by the State Food and Drug Administration (SFDA).
Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method (ADVATE) was approved for control and prevention of bleeding episodes in individuals with hemophilia A (congenital factor VIII deficiency).
It is estimated that more than 50,000 people in China are living with hemophilia A. The introduction of recombinant Factor VIII therapies in China offers new treatment options for hemophilia patients.
ADVATE is infused directly into the bloodstream and works by temporarily raising the level of factor VIII in the bloodstream, allowing the body's blood clotting process to properly function. Extensive global use and multiple clinical trials demonstrate clinical evidence for ADVATE. With SFDA's action, ADVATE is now approved in 54 countries worldwide.
Baxter continues to work closely with the Chinese hemophilia community, including both patients and treaters, to provide access to care for this life-saving, life-sustaining therapy.
In 2010, Baxter cooperated with the Ministry of Health to set up a "Hemophilia Disease Management System," China's first nationwide hemophilia patient registration and management system integrating diagnosis and treatment information.
In recent years, Baxter has donated more than 5 million internatonal units of hemophilia products to Chinese patients and has provided a number of resources to raise awareness of the disease.
Hemophilia is a rare genetic blood clotting disorder that primarily affects males. In people with hemophilia A, clotting factor VIII is not present in sufficient amounts or is absent. Without enough Factor VIII, people with hemophilia can experience spontaneous, uncontrolled internal bleeding that is painful, debilitating, damaging to joints and potentially fatal.
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