Baxter International Inc. reported positive results from a late-stage study evaluating routine use of its anti-inhibitor coagulant complex to treat Hemophilia, a rare genetic bleeding disorders .The data gathered will form the basis of a biologics license application to be filed with the U.S. health regulators in the first quarter of 2013. |
What does it investigate?
The Phase 3 clinical trial investigated the efficacy, safety and health-related quality of life benefits of its so-called anti-inhibitor coagulant complex prophylactic treatment given to maintain health and prevent bleeding compared with on-demand treatment. The study included 36 patients with Hemophilia A or B and inhibitors over a 12-month period. According to Baxter, “There was a 72.5 percent reduction in bleed rates for the prophylactic.”
What are the side effects discovered in the research?
The most commonly reported negative side effects in the study were hypersensitivity, dizziness, headache, rash, hypotension and Hepatitis B surface antibody, test positive in laboratory result. The occurrence of a transitory increase in Hepatitis B surface antibodies has been seen in certain plasma-derived products and could be attributed to the passive transfer of antibodies following treatment. The company has stated that, “None of the subjects showed any signs or symptoms of Hepatitis B infection.”
What happens to people with Hemophilia?
People living with Hemophilia do not have enough of, or are missing, one of the blood clotting proteins naturally found in blood. People with Hemophilia can experience spontaneous, uncontrolled internal bleeding that is potentially fatal. According to the World Federation of Hemophilia, “More than 400,000 people in the world have Hemophilia.”
What are the forms of Hemophilia?
The most common forms of the disease are Hemophilia A and Hemophilia B. While both types of hemophilia are caused by low levels or absence of one of the proteins in the blood that controls bleeding, people with Hemophilia A have a a deficiency or non-function of the critical co-factor “factor VIII” where as in Hemophilia B, there is a deficiency of the essential clotting factor, “factor IX.”
What will the research achieve?
Baxter’s drug, if approved, would potentially compete with Hemophilia drugs being developed by Biogen Idec Incorporated. In October, Biogen said its experimental treatment for patients with Hemophilia A controlled bleeding with fewer treatments in a late-stage clinical trial. According to Biogen, “The market for Hemophilia A treatment is worth about $5 billion, while the market for Hemophilia B treatment is about $1 billion.”
The drugs, if approved, would also compete with shorter-acting products, including Baxter’s market-leading drug Advate. Biogen filed recently for U.S. approval for its Factor IX product for Hemophilia B. The company is also on track to file for approval of its Factor VIII product for patients with Hemophilia A in the first half of 2013.
Visit for more information Hemophilia Non-Profit Donations
Related Articles -
what is hemophilia, hemophilia non-profit donations, bleeding disorders,