Baxter International Inc., a global, diversified healthcare company, has received approval from China State Food and Drug Administration (SFDA) for Advate [Recombinant Human Coagulation Factor VIII for injection] for the control and prophylaxis of bleeding episodes in individuals with haemophilia A (congenital factor VIII deficiency).
It is estimated that more than 50,000 people in China are living with haemophilia A.
“The introduction of recombinant FVIII therapies in China offers new treatment options for haemophilia patients. The launch of Advate is another step in advancing haemophilia 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 haematological institution providing basic medical research with clinical services in China.
“Great strides have been made in managing haemophilia, allowing people with this serious condition to live longer, more active and fulfilling lives than ever before,” said Guan Tao, secretary general of Haemophilia Home, the haemophilia patient organization in China. “The availability of Advate will be an important milestone for people with haemophilia in China.”
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 haemophilia," said Ludwig Hantson, PhD, president of Baxter's BioScience business.
Baxter continues to work closely with the Chinese haemophilia 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 “Haemophilia Disease Management System,” China's first nationwide haemophilia patient registration and management system integrating diagnosis and treatment information. In recent years, Baxter has donated more than five million IUs of haemophilia products to Chinese patients and has provided a number of resources to raise awareness of the disease.
Advate [Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method] was initially approved by the FDA in July 2003 for control and prevention of bleeding episodes in adults and children (0-16 years) with haemophilia A. Advate is a full-length (derived from the complete FVIII gene) recombinant FVIII product that is processed without any blood-based additives. Because no blood derived components are added at any stage of the manufacturing process, the potential risk of transmitting pathogens that may be carried in blood-based additives is eliminated. There have been no confirmed reports of transmission of HIV, HBV or HCV with rFVIII therapies.
Advate is approved in the United States, Canada, 27 countries in the European Union, Argentina, Australia, Brazil, Chile, China, Colombia, Croatia, Hong Kong, Iceland, Iraq, Japan, Macau, Malaysia, New Zealand, Norway, Panama, Puerto Rico, Serbia, Singapore, South Korea, Suriname, Switzerland, Taiwan, Uruguay and Venezuela.
In the United States, Advate [Antihemophilic Factor (Recombinant) Plasma/AlbuminFree Method] is also indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children (0-16 years) with haemophilia A. Advate is the only antihemophilic factor approved in the United States for prophylactic use in both adults and children. Advate is not indicated for the treatment of von Willebrand disease.
Haemophilia is a rare genetic blood clotting disorder that primarily affects males. People living with haemophilia do not have enough of, or are missing, one of the blood clotting proteins naturally found in blood. Two of the most common forms of haemophilia are A and B. In people with haemophilia A, clotting factor VIII is not present in sufficient amounts or is absent.
Baxter International Inc., develops, manufactures and markets products that save and sustain the lives of people with haemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions.