Chinese sFDA approves Baxter's ADVATE to treat hemophilia A
Published on May 17, 2012 at 1:55 AM
Baxter International Inc. (NYSE:BAX) today announced the approval of
ADVATE [Recombinant Human Coagulation Factor VIII for
injection] for the control and prophylaxis of bleeding episodes in
individuals with hemophilia A (congenital factor VIII deficiency) in
China by the State Food and Drug Administration (SFDA). It is estimated
that more than 50,000 people in China are living with hemophilia A.
''The introduction of recombinant FVIII therapies in China offers new
treatment options for hemophilia patients. The launch of ADVATE is
another step in advancing hemophilia care in China,'' said Professor
Yang Renchi, Institute of Hematology and Blood Diseases Hospital,
Chinese Academy of Medical Sciences and Peking Union Medical College,
the leading professional hematological institution providing basic
medical research with clinical services in China.
''Great strides have been made in managing hemophilia, allowing people
with this serious condition to live longer, more active and fulfilling
lives than ever before,'' said Guan Tao, Secretary General of Hemophilia
Home, the hemophilia patient organization in China. ''The availability
of ADVATE will be an important milestone for people with hemophilia in
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.
''The approval of ADVATE in China marks an important milestone for
Baxter and supports our ongoing commitment to treating individuals
living with hemophilia,'' said Ludwig Hantson, Ph.D., president of
Baxter's BioScience business.
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 five million IUs of
hemophilia products to Chinese patients and has provided a number of
resources to raise awareness of the disease.
Baxter International Inc.