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FDA Approves Hydroxyurea

http://www.sicklecelldisease.org/research/archive/hydrox.phtml

FDA APPROVES HYDROXYUREA

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FDA APPROVES IMPORTANT DRUG FOR TREATMENT OF SICKLE CELL DISEASE The Sickle Cell Disease Association of America, Inc. (SCDAA) is very pleased with the announcement by the Food and Drug Administration of the approval of hydroxyurea (under the brand name Droxia) for use in treating adult patients with sickle cell disease. This is the first time a drug has been approved specifically for use in this disease that affects tens of thousands of Americans and hundreds of thousands of others throughout the world. We would like to congratulate the investigators whose work led to the trail of hydroxyurea in sickle cell disease, the National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health for funding the clinical trails which demonstrated the safety and efficacy of hydroxyurea in sickle cell disease, the research investigators who conducted the trails, Bristol Myers-Squibb for their continued support of these studies and the brave patients whose courage in participating in these studies has made it possible for may others to be able to benefit from the new treatment. We hope that work on the safety of hydroxyurea in children with sickle cell disease will show soon that they can also be treated safely with the drug. Hydroxyurea is a well-known drug, however its use in sickle cell disease is relatively new and must be approached with caution. Short-term side effects must be carefully monitored and long-term effects are still unknown. Recognizing that many physicians are eager to provide this therapy to their patients, SCDAA feels it is important to stress that each physician treating sickle cell patients throughout the country must be educated about the proper use and monitoring of hydroxyurea therapy prior to initiating such treatment. Through its 65 Member Organizations, SCDAA will be happy to work with Bristol Myers-Squibb, NHLBI and other health agencies to ensure that physicians and patients are educated about this new treatment. POTENTIAL SAVINGS FROM USE OF HYDROXYUREA Estimated total U.S. sickle cell patients 65,000 * 5.2% 3,380 4 13,520

Percent with severe pain 3-5 times per year Estimated number with frequent severe pain

Assuming the average annual number of episodes

The total number of severe pain episodes in these patients Assuming that 50% episodes result in hospitalization Assuming the average days of hospitalization 5 6,760

Estimated total number of hospital days for these patients Assuming cost per day $800 $27,040,000

33,800

Total hospitalization costs for these patients

Potential savings from use of hydroxyurea in these patients in one year * Estimates of sickle cell disease patients in the U.S. is now over

$13,520,000

70,000.

Copyright © 2005 Sickle Cell Disease Association of America, Inc.

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12/10/2010 5:39 PM

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