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Clinical Data Suggest Decreased Bleeding Risk in People With Severe,Hemophilia A While Maintaining Factor VIII Levels Above One Percent

activity and bleeding patterns.

About Hemophilia A

People with hemophilia A do not produce adequate amounts of factor VIII, which is necessary for blood to effectively clot. If untreated, patients with severe hemophilia A have a greatly reduced life expectancy. According to the World Health Organization, more than 400,000 people in the world have hemophilia, corresponding to a prevalence of 15 to 20 in every 100,000 males born worldwide.

About ADAPT

The ADAPT (Analysis of Data from ADVATE Prospective Trials) research program was initiated to further investigate and explore the expanding ADVATE clinical study program database for additional insight into general hemophilia medical research and practice issues beyond the main goals of the Investigational New Drug (IND) research program. ADAPT research goals include examining the reliability and reproducibility of certain pharmacokinetic (PK) measurements across a broad population of subjects. Such PK data may be important to clinical development and evaluation of new therapeutics, as well as for the prediction of relationships to clinical outcomes and their utility in optimizing the routine clinical management of hemophilia A. These studies may offer guidance for designing individualized dosing regimens based on patient PK profiles, which may allow for less frequent infusion requirements or improved treatment outcomes.

It is important to note that prophylaxis is not an approved therapy regimen in some countries, including the United States. On-demand is the approved dosage regimen for most factor VIII therapies in the United States.

About ADVATE

ADVATE is currently approved for use in the United States, Australia, Japan and Europe.

ADVATE is indicated in hemophilia A (classical hemophilia) for the prevention and control of bleeding episodes. ADVATE is also indicated in the perioperative management of patients with hemophilia A. ADVATE is not indicated for the trea
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