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01 / 24 / 2002
FDA ADVISORY COMMITTEE REJECTS NEW RAPAMUNE® REGIMEN
Madison, N.J. (January 24, 2002) - Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products Corporation (NYSE: AHP), announced today that an application for a new indication for Rapamune (sirolimus), the Company’s immunosuppressant agent for prevention of organ rejection following renal transplantation, was not recommended for approval by the Immunosuppressive Drugs Subcommittee of the FDA Antiviral Drugs Advisory Committee. The Committee was considering a new Rapamune maintenance regimen that would allow physicians to eliminate cyclosporine two to four months after transplantation.
"The 5-4 vote reflected comments on the applicability of the data to the renal transplant population in the United States," says Joseph Camardo, Senior Vice President, Clinical Research, Wyeth-Ayerst Research. "The Committee acknowledged that patient and graph survival were good and that renal function did improve in the population. We plan to meet with the FDA to discuss suggested additional analyses and to discuss their response to the mixed review at the Advisory Committee."
In 1999, RAPAMUNE was approved for the prophylaxis of organ rejection in patients receiving kidney transplants. Currently, it is recommended in the U.S. that RAPAMUNE be used in a regimen concomitantly with cyclosporine and corticosteroids.
Kidney transplantation is the most common type of transplant procedure in the United States. To help reduce the risk of organ rejection, transplant patients are given a lifelong regimen of immunosuppressant agents. These drugs are intended to blunt the body’s normal immune response, allowing the transplanted organ to remain functional.
RAPAMUNE is the first of a distinctive class of immunosuppressants known as TOR inhibitors. TOR stands for target of rapamycin, a key regulatory kinase involved in cell cycle progression.
Safety Information
Increased susceptibility to infection and the possible development of lymphoma and other malignancies, particularly of the skin, 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.
Increased serum cholesterol and triglycerides that may require treatment occurred more frequently in patients treated with RAPAMUNE compared to azathioprine or placebo controls. Mean serum creatinine was increased and mean glomerular filtration rate was decreased in patients treated with RAPAMUNE and cyclosporine compared to those treated with cyclosporine and placebo or azathioprine controls. Renal function should be monitored during the administration of maintenance immunosuppression regimens including RAPAMUNE in combination with cyclosporine, and appropriate adjustment of the immunosuppression regimen should be considered in patients with elevated serum creatinine levels. Caution should be exercised when using agents that are known to impair renal function.
Specific adverse reactions associated with RAPAMUNE administration occurring at a significantly higher frequency vs. controls include for both 2 and 5 mg/day: hypercholesterolemia, hyperlipidemia, lymphocele, hypertension, elevated lactate dehydrogenase, and rash; for 5 mg/day: anemia, arthralgia, diarrhea, hypokalemia, and thrombocytopenia; and for 2 mg/day: acne. Elevations of triglycerides and cholesterol, and decreases in platelets and hemoglobin occurred in a dose-related manner.
About the Company
Wyeth-Ayerst Laboratories, a division of American Home Products Corporation, is a major research-oriented pharmaceutical company with leading products in the areas of women’s health care, cardiovascular therapies, central nervous system drugs, musculoskeletal therapies, infectious disease, hemophilia, oncology, and vaccines.
American Home Products Corporation is one of the world’s largest research-based pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of prescription drugs and over-the-counter medications. It is also a leader in vaccines, biotechnology, and animal health care.
Media Contacts:
Douglas Petkus
Wyeth-Ayerst Laboratories
(610) 902-7336
Lowell Weiner
American Home Products
(973) 660-5013
Investor Contact:
Justin R. Victoria
American Home Products
(973) 660-5340