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FDA Approves Bayer HealthCare's Kogenate(R) FS Treatment for Routine Prophylaxis in Children with Hemophilia A
Date:10/10/2008

pre-existing joint damage is based on the clinical data from a multicenter trial in the U.S. that included 65 boys with severe hemophilia A less than 30 months of age at study entry. Study participants were followed for up to 5.5 years. This Joint Outcomes Study (JOS), conducted over a 10-year period, was led by Marilyn J. Manco-Johnson, M.D., Professor of Pediatrics and Associate Professor of Pathology in the Department of Pediatrics, University of Colorado at Denver and Health Science Center, and Director of the Mountain States Regional Hemophilia & Thrombosis Center at the University of Colorado. Key findings from the JOS study, published in the August 9, 2007 issue of The New England Journal of Medicine(2), include:

-- 93 percent of the participants in the routine prophylaxis group showed

normal joint function, in contrast to 55 percent in the episodic group.

-- Kogenate FS prophylaxis treatment was able to preserve the joint even if

the child had less than or equal to two bleeds per index joint.

-- Patients from the prophylaxis group were eight times more likely to have

damage-free joints than those from the episodic group.

-- The prophylaxis group had an 81.5 percent reduction in annual bleeding

frequency compared to the episodic group.

-- Overall, there was an 83 percent reduction in the risk for joint damage

in patients receiving prophylaxis from an early age.

-- Ten percent of the patients treated episodically experienced

life-threatening bleeds compared to zero patients treated

prophylactically.

-- The most common adverse events were related to central venous access,

such as catheterization and catheter removal, central line infection and

pyrexia.

The study was designed with special emphasis on the "index joints," including the elbow, knee and ankle joints, which are most prone to bleeding in severe hemoph
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SOURCE Bayer HealthCare
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