Submission of an Automated Test for Monitoring Transplant Drug Rapamune® (Sirolimus)

Main Category: Transplants / Organ Donations
Article Date: 12 Sep 2004 - 0:00 PDT

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Therapeutic Drug Monitoring (TDM) Tests Help Doctors Manage Patient Care and are an Important Part of the Treatment Process.

Abbott Laboratories, through a collaboration with Wyeth, today announced that its manufacturing partner, Axis-Shield, has submitted a 510(k) Premarket Notification with the US Food and Drug Administration (FDA) seeking clearance of a sirolimus test for use on Abbott's IMx® System. Widely used in hospital laboratories throughout the world, the IMx automated immunoassay analyzer is a benchtop system that is easy-to-use, providing quick turnaround times for patient samples, and features an extensive testing menu. RAPAMUNE® (sirolimus), a Wyeth anti-rejection drug, is an immunosuppressant agent indicated for renal transplants. In August, Abbott introduced the IMx® Sirolimus assay in other major markets throughout the world.

"Abbott has a strong history in providing assays to monitor therapeutic drugs, especially in the area of transplant diagnostics," said William Brown, Ph.D., vice president, Diagnostic Assays and Systems Development, Abbott Laboratories. "These tests are vital to helping doctors manage patient care and an important part of the treatment process."

To help reduce the risk of organ rejection, transplant patients are given a regimen of immunosuppressant agents. These drugs are intended to lower the body's normal immune response, allowing the transplanted organ to remain functional.

In 2003, Abbott and Wyeth entered into a joint agreement to develop a sirolimus test for use on Abbott's IMx and other automated immunoassay systems.

Other Abbott tests available for monitoring immunosuppressant drugs include cyclosporine and tacrolimus.

About RAPAMUNE® (sirolimus)

RAPAMUNE is indicated for the prophylaxis of organ rejection in patients receiving renal transplants. It is recommended that RAPAMUNE be used initially in a regimen with cyclosporine and corticosteroids. In patients at low to moderate immunologic risk cyclosporine should be withdrawn 2 to 4 months after transplantation and RAPAMUNE dose should be increased to reach recommended blood concentrations.

The safety and efficacy of cyclosporine withdrawal in high-risk patients have not been adequately studied and it is therefore not recommended. This includes patients with Banff grade III acute rejection or vascular rejection prior to cyclosporine withdrawal, those who are dialysis-dependent, or with serum creatinine >4.5 mg/dL, African-American patients, re-transplants, multi-organ transplants, patients with high panel of reactive antibodies.

Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of renal transplant patients should use RAPAMUNE. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient. Complete prescribing information for RAPAMUNE is available at http://www.rapamune.com.

About Axis-Shield

Axis-Shield is a global manufacturer of in vitro diagnostic kits with a focus on new markers in cardiovascular, rheumatoid, infectious and alcohol-related diseases, diabetes, dementia and near patient testing to facilitate improved patient management. Axis-Shield has partnered with Abbott to introduce several new tests on both the IMx® and AxSYM® systems, Abbott's market-leading automated immunoassay analyzers. News releases and company information are available at http://www.axis-shield.com.

About Wyeth

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, cardiovascular disease, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products and nonprescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.

About Abbott Laboratories

Abbott Laboratories is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 55,000 people and markets its products in more than 130 countries.

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