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Astellas Seeks Rigorous Testing and Safety-Related Labeling for Anti-Rejection Medications
Date:8/10/2009

formulation is about to be provided to a transplant patient so that the physician can determine whether additional drug blood concentration testing should be done to ensure the health and safety of the patient. Astellas is also challenging this part of the FDA's decision.

"As a leader in the field of immunology, Astellas is firmly committed to the appropriate care and treatment of transplant patients. Transplant physicians are the most qualified to make decisions about their patient's treatment and should be informed when the patient's medication is switched from one formulation to another," said William E. Fitzsimmons, Pharm.D., M.S., Senior Vice President, Development. "This is a specialized category of medicine and transplant patients are vulnerable to small differences in drug concentrations, which can lead to significant differences in their treatment outcome. We look forward to open discussion about this important issue."

About Organ Transplantation

There are nearly 100,000 patients on the waiting list for an organ transplant and 4,000 patients are added to the list each month. Each day, on average, seventeen patients on the list die waiting for a life-saving organ transplant.

"Due to the scarcity of organs and the potential for rejection, maintaining the delicate balance and life-preserving functions of transplanted organs is of primary importance," said Goran B. Klintmalm, M.D., Ph.D., Director, Transplantation Services, Baylor University Medical Center, Dallas, Texas, Chairman and Chief, Baylor Regional Transplant Institute, and Immediate Past-President of the American Society of Transplant Surgeons. "For more than 25 years immunosuppressant therapy has been a standard of care for transplant patients to help prevent organ rejection. It is important that the efficacy and safety profile of these drugs remain consistent to ensure transplant patients are able to receive the best pos
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SOURCE Astellas Pharma US, Inc.
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